CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.
Adalimumab – Humira
| Study Name | |||
|---|---|---|---|
| M02-574 | Rheumatoid Arthritis | Phase 3 | A Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody (D2E7) in Patients with Active Rheumatiod Arthritis |
| M12-073 | Rheumatoid Arthritis | Phase 3 | A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis (CONCERTO) |
| M02-527 | Rheumatoid Arthritis | Phase 4 | A mulit-centre randomised, double-blind study comparing adalimumab (D2E7) plus methotrexate with placebo plus methotrexate on work disability in subjects with early rheumatoid arthritis |
| P10-733 | Rheumatoid Arthritis | PMOS | Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis |
| PMOS-CANA-04-01 | Rheumatoid Arthritis | PMOS | Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA |
| M03-651 | Rheumatoid Arthritis | Phase 3 | Open-Label Continuous Administration Study with Adalimumab (D2E7) in Subjects with Rheumatoid Arthritis |
| M13-687 | Crohn's Disease | Phase 3 | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease |
| M11-991 | Ankylosing Spondylitis | Phase 3 | A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis |
| M04-702 | Psoriasis | Phase 2 | A Multicenter Open-Label Continuation Study of the Long-term Safety and Efficacy of Adalimumab (D2E7) in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| M13-606 | Psoriasis | Phase 3 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects with Moderate to Severe Plaque Psoriasis |
| W13-984 | Ankylosing Spondylitis | Phase 4 | Rapidity of onset of response to adalimumab in luminal Crohn's disease. RAPIDA study |
| W05-399 | Psoriatic Arthritis | CSR.ORG | A Canadian Open-label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Tre... |
| W12-122 | Rheumatoid Arthritis | Phase 4 | Radiographic, Clinical and Patient outcomes in a multicenter, open-label phase IV randomized trial of earlier Adalimumab introduction therapy versus later introduction as per standard of care after initial Methotrexate failure in Early Rheumatoid Arthritis patients (RADAR) |
| P13-708 | Rheumatoid Arthritis | PMOS | A Prospective, Multi-Center Study in Rheumatoid Arthritis Patients on Adalimumab to Evaluate its Effect on Synovitis Using Ultrasonography in an Egyptian Population |
| M03-596 | Psoriasis | CSR.ORG | Phase 2 Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis A… |
| HUM 03-1 | Rheumatoid Arthritis | PMOS | Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice |
| M03-656 | Psoriasis | CSR.ORG | A Phase 3, Multicenter Study of the Efficacy and Safety of Long-term Adalimumab Treatment in Subjects with Moderate to Severe C… |
| P15-084 | Psoriatic Arthritis | PMOS | Special Investigation (Working Productivity and Activity Impairment in Japanese Patients with Psoriatic Arthritis) |
| M13-279 | Psoriasis | Phase 4 | An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation |
| MEXI-P01-03 | Rheumatoid Arthritis | Phase 3 | Quality of Life Study with Adalimumab in Rheumatoid Arthritis D2E7, adalimumab, HUMIRA, Phase 3, Phase III, Rheumatoid Arthritis, RA |
| M02-527 | Rheumatoid Arthritis | CSR.ORG | A Multi-centre Randomised, Double-blind Study Comparing Adalimumab (D2E7) Plus MTX With Placebo Plus MTX on Work Disability in S… |
| M04-688 | Psoriasis | CSR.ORG | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Adalimumab (D2E7) in Jap... |
| M10-880 | Uveitis | Phase 3 | A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Inactive Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis – Including a Sub-study in Japanese Patients |
| W06-405 | Crohn's Disease | Phase 3 | A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects with Moderate to Severe Crohn’s Disease (ACCESS) |
| M11-327 | Uveitis | Phase 3 | A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis |
| M02-573 | Rheumatoid Arthritis | CSR.ORG | A Randomized, Double-Blind, Placebo-Controlled, Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Inj... |
| M04-691 | Crohn's Disease | Phase 3 | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab |
| M02-570 | Psoriatic Arthritis | CSR.ORG | A Phase III Multicenter Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Moderate to… |
| M05-769 | Crohn's Disease | Phase 3 | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon |
| M06-829 | Crohn's Disease | Phase 3 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease |
| W06-406 | Rheumatoid Arthritis | Phase 3 | An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients with Active Rheumatoid Arthritis |
| P15-777 | Rheumatoid Arthritis | PMOS | Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Korea |
| P14-190 | Ulcerative Colitis | PMOS | HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special investigation on Long-Term administration Ulcerative Colitis |
| M02-498 | Rheumatoid Arthritis | CSR.ORG | A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects with Active Rheumatoid Arthritis Abb... |
| M04-716 | Psoriasis | CSR.ORG | A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of A… |
| P15-673 | Gastrointestinal | Phase 4 | Post-marketing observational study to evaluate the effect of adalimumab (Humira) treatment with AbbVie's patient support program on patient reported outcomes and health resource utilization in inflammatory arthritis, psoriasis, and inflammatory bowel diseases in Hungary in a real-life setting |
| P12-261 | Psoriasis | PMOS | Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy |
| HUM 05-3 | Psoriatic Arthritis | Phase 4 | A long term documentation to demonstrate long term efficacy and safety of Humira® in patients with psoriatic arthritis under conditions of daily practice |
| W11-050 | Psoriasis | Phase 4 | Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis |
| M02-538 | Psoriasis | CSR.ORG | Phase 2 Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis. Abbott Labo… |
| P10-448 | Rheumatoid Arthritis | PMOS | Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice |
| M02-497 | Rheumatoid Arthritis | Phase 3 | An open-label, multi-center study to assess the safety and efficacy of the fully human anti-TNF monoclonal antibody Adalimumab (D2E7) when added to inadequate standard anti-rheumatic therapy in patients with active rheumatoid arthritis |
| M02-574 | Rheumatoid Arthritis | CSR.ORG | A Multicenter Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients with Active… |
| M06-808 | Crohn's Disease | Phase 3 | A Multi-center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients with Moderate to Severe Crohn's Disease with Previous Exposure to Infliximab |
| M14-193 | Psoriasis | Phase 3 | A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects with Generalized Pustular Psoriasis |
| P13-983 | Rheumatoid Arthritis | PMOS | Assessment of the safety of adalimumab in rheumatoid arthritis (RA) patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying antirheumatic drugs (DMARDs) or biological agents |
| M10-261 | Rheumatoid Arthritis | Phase 3 | A Multi-center, Randomized, Double-blind, Placebo-controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared with 40 mg Adalimumab Every Other Week Dosing |
| P10-559 | Rheumatoid Arthritis | PMOS | Humira 40mg/0.8ml for Subcutaneous Injection-Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis |
| M12-088 | Rheumatoid Arthritis | Phase 2 | A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients |
| M04-688 | Psoriasis | Phase 2 | A Phase 2/3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Adalimumab (D2E7) in Japanese Subjects with Moderate to Severe Chronic Plaque Psoriasis |
| M02-537 | Psoriatic Arthritis | CSR.ORG | A Phase III Multicenter Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Moderate to… |
| P12-768 | Ankylosing Spondylitis | PMOS | Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis |
| P11-973 | Rheumatoid Arthritis | PMOS | Long-term Documentation of the Safety, Effectiveness, and Effects on Quality of Life and Work Productivity in Patients with Rheumatoid Arthritis during HUMIRA® (Adalimumab) Therapy in Routine Clinical Practice (AGIL) and Supplementary Documentation to Record Cardiovascular and Metabolic Risk Factors (AGIL-CV) |
| M03-596 | Psoriasis | Phase 2 | A Phase II Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis |
| MEXI-P01-03 | Rheumatoid Arthritis | CSR.ORG | Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR. Abbott Laboratories (Abbott) will use reasonable… |
| M02-529 | Psoriasis | CSR.ORG | A Phase II Multicenter Extension Study of the Safety and Efficacy of Adalimumab (D2E7) in Subjects with Moderate to Severe Chronic Plaque Psoriasis Gordon KB, Langley RG, Leonardi C, et al. Clinical Response to Adalimumab Treatment in Moderate to Severe Psoriasis Patients: Double-Blind, Randomized Clinical |
| M05-775 | Rheumatoid Arthritis | Phase 3 | A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis |
| DE038 | Rheumatoid Arthritis | CSR.ORG | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti… |
| M06-806 | Crohn's Disease | Phase 3 | A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease |
| M03-600 | Rheumatoid Arthritis | CSR.ORG | Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects with Rheumatoid Arth... |
| W10-045 | Rheumatoid Arthritis | Phase 4 | Open-Label, Multi-country and Multi-Center Study to Assess the Clinical Efficacy and impact on QoL of the Fully Human Anti-TNF-alfa Monoclonal Antibody Adalimumab (Humira) when Added to Inadequate Standard Anti-Rheumatic Therapy in patients with Active Rheumatoid Arthritis in a period of 6 months treatment |
| P15-619 | Crohn's Disease | PMOS | Post-Marketing Surveillance of Humira Injection in Korean Pediatric CD Patients under the "New-Drug Re-examination" |
| M10-240 | Juvenile Idiopathic Arthritis | Phase 3 | A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis |
| P12-070 | Rheumatoid Arthritis | PMOS | Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis) |
| M05-770 | Rheumatoid Arthritis | Phase 2 | Trial of Usability in Clinical Settings of the Humira Autoinjector vs Pre-filled Syringe (TOUCH) |
| M02-538 | Psoriasis | Phase 2 | A Phase II Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis |
| P12-265 | Rheumatoid Arthritis | PMOS | An Observational Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia |
| M10-239 | Ankylosing Spondylitis | Phase 3 | A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis |
| M04-684 | Rheumatoid Arthritis | Phase 4 | Humira Efficacy Response Optimization Study in Subjects with Active Rheumatoid Arthritis (HERO) |
| P12-129 | Psoriasis | PMOS | Evaluation of Humira Retention Rate in Psoriasis in Daily Practice and Assessment of Work Productivity and Quality of Life |
| DE018 | Rheumatoid Arthritis | CSR.ORG | A Multi-center Open-Label Continuation Study with Subcutaneous D2E7 for Patients with Rheumatoid Arthritis Who Completed a Precedi… |
| DE038 | Juvenile Idiopathic Arthritis | Phase 3 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children |
| M02-537 | Psoriatic Arthritis | Phase 2 | A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients with Moderate to Severely Active Psoriatic Arthritis |
| M11-964 | Rheumatoid Arthritis | Phase 2 | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis |
| P13-990 | Ankylosing Spondylitis | PMOS | Observational study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) patients to evaluate work productivity before and after the start of adalimumab therapy in daily practice in Belgium (SPACTIVE) |
| M02-404 | Crohn's Disease | CSR.ORG | A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the I… |
| M02-433 | Crohn's Disease | Phase 3 | A multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects with Crohn's Disease |
| M10-877 | Uveitis | Phase 3 | A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis – Including a Sub-study in Japanese Patients |
| M10-467 | Hidradenitis Suppurativa (HS) | Phase 2 | A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis Suppurativa |
| M03-658 | Psoriasis | Phase 3 | A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects who Completed a Preceding Psoriasis Clinical Study with Adalimumab |
| M13-390 | Rheumatoid Arthritis | Phase 2 | Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis |
| M03-583 | Rheumatoid Arthritis | CSR.ORG | Multicenter Early Access Program (EAP) of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active R... |
| M06-859 | Rheumatoid Arthritis | Phase 3 | A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis |
| W10-151 | Psoriasis | Phase 3 | A Canadian Open-Label Access Program to Evaluate the Safety and the Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis (PRIDE) |
| M10-060 | Psoriasis | Phase 3 | A Multi-center Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination with Topical Treatment (Calcipotriol/Betamethasone) in Subjects with Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE) |
| M04-724 | Rheumatoid Arthritis | CSR.ORG | Safety and Efficacy of Adalimumab in Patients with Active Psoriatic Arthritis (PsA) An Open-label, Multinational Study to Eva… |
| P13-974 | Crohn's Disease | PMOS | An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a Korean Experience |
| P12-069 | Rheumatoid Arthritis | PMOS | Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)) |
| M13-375 | Ankylosing Spondylitis | Phase 3 | A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non-Radiographic Axial Spondyloarthritis |
| M14-232 | Crohn's Disease | Phase 2 | A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects with Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein |
| P13-684 | Rheumatoid Arthritis | Phase 4 | Assessment of clinical effectiveness and safety of adalimumab and high dose methotrexate in routine clinical practice |
| P10-147 | Ankylosing Spondylitis | PMOS | Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice |
| P15-778 | Rheumatoid Arthritis | PMOS | Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan |
| M10-444 | Juvenile Idiopathic Arthritis | Phase 3 | Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use |
| M02-518 | Psoriatic Arthritis | CSR.ORG | A Phase III Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Subjects… |
| P12-165 | Psoriasis | PMOS | Effectiveness of Adalimumab (Humira) in the Treatment of Scalp and Nail Affection in Patients with Moderate to Severe Plaque Psoriasis in Routine Clinical Practice |
| M12-783 | Rheumatoid Arthritis | Phase 2 | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis. |
| M02-497 | Rheumatoid Arthritis | CSR.ORG | An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-á Monoclonal Antibody Adalimuma… |
| P12-770 | Psoriasis | PMOS | Effectiveness of Adalimumab in moderate to severe Plaque Psoriasis Patients with distinct Co-morbidities |
| P11-067 | Psoriasis | PMOS | Post-Authorization, Observational Study to Evaluate the Effectiveness of Adalimumab (HUMIRA®) on Moderate-Severe Psoriasis under Conditions of Normal Clinical Practice in Spain |
| M06-827 | Ulcerative Colitis | Phase 3 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis |
| P13-683 | Rheumatoid Arthritis | PMOS | Physical Activity in Patients with Rheumatoid Arthritis Treated with Adalimumab in Routine Clinical Practice |
| P13-562 | Rheumatoid Arthritis | PMOS | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn’s Disease and Ulcerative Colitis patients`adherence attitudes to maintenance therapy with a scheduled Adalimumab treatment in routine clinical practice |
| M02-532 | Rheumatoid Arthritis | Phase 3 | An Open-Label Study to Assess the Efficacy and Safety of the Fully Human Anti-TNF-alpha Monoclonal Antibody Adalimumab (D2E7) in patients with active Rheumatioid Arthritis who have failed Previous Treatment with Infliximab (Remicade) |
| M06-826 | Ulcerative Colitis | Phase 3 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis |
| M04-716 | Psoriasis | Phase 3 | A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis |
| M12-071 | Rheumatoid Arthritis | Phase 4 | A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA) |
| P12-772 | Rheumatoid Arthritis | PMOS | The documentation of the effects on Quality of Life (QOL) and Working Productivity and Activity Impairment (WPAI) in patients with rheumatoid arthritis (RA) under HUMIRA® (Adalimumab) in routine clinical practice. |
| P14-152 | Intestinal Behcet's | PMOS | Humira® 40mg Syringe 0.8mL Subcutaneous Injection. Special Investigation in Patients With Intestinal Behcet's Disease |
| M05-760 | Ankylosing Spondylitis | Phase 3 | Review of Safety and Efficacy With Adalimumab in Patients with Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors (RHAPSODY) |
| P13-338 | Crohn's Disease | PMOS | IDEA Study: Improvement of Work Productivity and Quality of Life with anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey |
| M03-583 | Rheumatoid Arthritis | Phase 4 | Early Access Program (EAP) M03-583 Multicenter Early Access Program (EAP) of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis |
| P12-705 | Crohn's Disease | Phase 4 | Reveal the Level of Anxiety in Patients with Crohn's Disease Receiving Adalimumab |
| HUM04-28 | Rheumatoid Arthritis | PMOS | A five-year, post marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA® (adalimumab) |
| DE018 | Rheumatoid Arthritis | Phase 3 | A Multi-Centre Open Label Continuation Study with Subcutaneous D2E7 (adalimumab) for Patients with Rheumatoid Arthritis Who Completed a Preceding Clinical Study with D2E7 (adalimumab) |
| M10-791 | Spondyloarthritis | Phase 3 | A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis |
| P12-707 | Rheumatoid Arthritis | PMOS | An extended observational study (P12-707: HOPEFUL III Study) of follow-up survey (P12-069: HOPEFUL II study) of the study of adalimumab (D2E7) for prevention of joint destruction in patients with rheumatoid arthritis in Japan (M06-859) |
| M03-634 | Rheumatoid Arthritis | PMOS | A Five-Year, Post-Marketing Observational Study to Follow-up Patients with Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed HUMIRA® |
| M02-529 | Psoriasis | Phase 2 | A Phase 2 Multicenter Extension Study of the Safety and Efficacy of Adalimumab (D2E7) in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| M02-403 | Crohn's Disease | CSR.ORG | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Human Anti-TNF Monoclonal Antibody Adalimumab for the Induc… |
| P12-179 | Rheumatoid Arthritis | PMOS | A 2-year HRQL Observational Study Evaluating the Effect of Treatment with Adalimumab on Work Productivity and Sleep in Patients with Rheumatic Diseases in Greece. |
| M03-607 | Ankylosing Spondylitis | Phase 3 | A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Ankylosing Spondylitis |
| M03-656 | Rheumatoid Arthritis | Phase 3 | A Phase 3, Multicenter Study of the Efficacy and Safety of Long-term Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis |
| M12-555 | Hidradenitis Suppurativa (HS) | Phase 3 | A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa – PIONEER (Open-Label Extension) |
| P13-170 | Crohn's Disease | PMOS | HUMIRA 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation (Long-term treatment for Crohn's Disease patients) |
| P12-706 | Crohn's Disease | PMOS | Special Investigation (All cases investigation in patients with Crohn's Disease) |
| M04-724 | Psoriatic Arthritis | Phase 3 | Safety and Efficacy of Adalimumab in Patients with Active Psoriatic Arthritis (PsA) An Open-label, Multinational Study to Eva… |
| W14-406 | Psoriasis | Phase 3 | Concomitant longitudinal evaluation of adalimumab with methotrexate in the real world: the CLEAR study |
| M02-532 | Rheumatoid Arthritis | CSR.ORG | An Open-Label Study to Assess the Efficacy and Safety of the Fully Human Anti-TNF-alpha Monoclonal Antibody Adalimumab (D2E7) i… |
| P15-692 | Hidradenitis Suppurativa (HS) | PMOS | Post Marketing Observational Study to Assess Quality of Life Changes in Swedish Patients with Moderate or Severe Hidradenitis Suppurativa after 6 Months on Adalimumab Treatment |
| M02-575 | Rheumatoid Arthritis | CSR.ORG | A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose-Ranging Study of Subcutaneously Administered A… |
| P12-072 | Rheumatoid Arthritis | PMOS | A Post-Marketing Observational Study to Determine the Effectiveness and Patient Satisfaction with Adalimumab (Humira®) Treatment in Patients with Rheumatoid Arthritis (RA) (PASSION) |
| P13-682 | Rheumatoid Arthritis | PMOS | Impact of Adalimumab Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients with Ankylosing Spondylitis in Clinical Practice |
| P12-678 | Psoriasis | Phase 4 | Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis |
| P15-345 | Crohn's Disease | PMOS | An Observational Study of the Effectiveness of Adalimumab on Health and Disability Outcomes in New Zealand Patients with Immune-Mediated Inflammatory Diseases (VITALITY) |
| M11-328 | Ankylosing Spondylitis | Phase 3 | A Double-Blind, Placebo -Controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis |
| DE020 | Rheumatoid Arthritis | Phase 3 | A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis |
| M06-807 | Crohn's Disease | Phase 3 | A Multi-center, Open-label Study of the Human Anti−TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study |
| M10-405 | Psoriasis | Phase 4 | Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet |
| M04-684 | Rheumatoid Arthritis | CSR.ORG | HUMIRA Efficacy Response Optimization Study in Subjects with Active Rheumatoid Arthritis (HERO) Abbott Laboratories (Abbott)… |
| W10-046 | Rheumatoid Arthritis | Phase 4 | A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (ADMIRE) |
| M04-690 | Crohn's Disease | Phase 3 | Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease |
| M10-447 | Ulcerative Colitis | Phase 3 | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis |
| P15-238 | Ankylosing Spondylitis | PMOS | A Prospective, Mono-Country, Multi-Center Study to observe the frequency of Extra-Axial symptoms in Korean Ankylosing Spondylitis patients on adalimumab therapy |
| M02-564 | Rheumatoid Arthritis | Phase 2 | Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis |
| W05-399 | Psoriatic Arthritis | Phase 3 | A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM) |
| W06-407 | Rheumatoid Arthritis | Phase 4 | Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR) |
| P12-627 | Psoriasis | PMOS | A Real World Observational Study to Evaluate the Impact of Adalimumab Therapy on Quality of Life and Psychological Factors Associated With Severe Psoriasis |
| M03-606 | Ankylosing Spondylitis | Phase 3 | A Phase III Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Ankylosing Spondylitis |
| DE013 | Rheumatoid Arthritis | Phase 3 | A Prospective Multi-Center Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week with Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate (MTX) Administered over 2 Years in Patients with Early Rheumatoid Arthritis (PREMIER) |
| M02-573 | Rheumatoid Arthritis | Phase 3 | A Randomized, Double-Blind, Placebo-Controlled, Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate |
| P06-134 | Crohn's Disease | PMOS | A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Subjects with Moderately to Severely Active Crohn's Disease (CD) |
| M13-692 | Rheumatoid Arthritis | Phase 2 | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab |
| M04-717 | Psoriasis | Phase 3 | A Multicenter, Randomized, Double-Dummy, Double-Blind Study Evaluating Two Doses of Adalimumab versus Methotrexate (MTX) in Pediatric Subjects with Chronic Plaque Psoriasis (Ps) |
| M10-883 | Spondyloarthritis | Phase 3 | A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Peripheral Spondyloarthritis |
| M11-313 | Hidradenitis Suppurativa (HS) | Phase 3 | A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER I |
| M02-556 | Rheumatoid Arthritis | CSR.ORG | A Randomized, Double-Blind, Placebo-controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcut… |
| M04-691 | Crohn's Disease | CSR.ORG | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the... |
| M05-770 | Patient Preference Rheumatoid Arthritis Device | CSR.ORG | Trial of Usability in Clinical Settings of the HUMIRA Autoinjector vs. Pre-filled Syringe (TOUCH) Abbott Laboratories (Abbott… |
| M06-810 | Rheumatoid Arthritis | Phase 4 | A Multicenter, Randomized, Double-Period, Double − Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis (OPTIMA) |
| M02-575 | Rheumatoid Arthritis | Phase 3 | A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose-Ranging Study of Subcutaneously Administered Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis |
| P10-604 | Rheumatoid Arthritis | PMOS | Clinical Outcomes, Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab. A Multicenter Post-Marketing Observational Study in Routine Clinical Use |
| M14-347 | Crohn's Disease | Phase 3 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease |
| M04-729 | Crohn's Disease | Phase 3 | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease |
| P12-585 | Rheumatoid Arthritis | PMOS | Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis patients who are about to be treated with Adalimumab |
| M04-705 | Rheumatoid Arthritis | Phase 3 | A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate |
| M02-556 | Rheumatoid Arthritis | Phase 3 | A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated with Methotrexate |
| P10-278 | Crohn's Disease | PMOS | Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice. |
| DE019 | Rheumatoid Arthritis | Phase 3 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate |
| M06-837 | Crohn's Disease | Phase 3 | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease |
| M13-045 | Ulcerative Colitis | Phase 3 | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting |
| M10-238 | Psoriasis | Phase 3 | Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy |
| M11-271 | Crohn's Disease | Phase 3 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease (CD) |
| P12-769 | Juvenile Idiopathic Arthritis | Phase 4 | Humira® for Subcutaneous Injection Special Investigation (All-case survey) in Patients with Juvenile Idiopathic Arthritis |
| M02-404 | Crohn's Disease | Phase 3 | A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease |
| M13-674 | Nail Psoriasis | Phase 3 | A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Subjects with Chronic Plaque Psoriasis. |
| P12-764 | Ankylosing Spondylitis | PMOS | Special Investigation (All Cases Investigation in Patients with Ankylosing Spondylitis) |
| M14-233 | Crohn's Disease | Phase 3 | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients with Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein |
| P14-362 | Juvenile Idiopathic Arthritis | PMOS | Post-Marketing Surveillance of Humira® Injection in Korean JIA Patients under the New-Drug Re-examination |
| P13-194 | Rheumatoid Arthritis | PMOS | A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients with Moderately to Severely Active Rheumatoid Arthritis in China |
| M02-528 | Psoriasis | CSR.ORG | A Phase 2, Multicenter Study of the Safety and Efficacy of Adalimumab (D2E7) in Subjects with Moderate to Severe Chronic Plaque Psor... |
| M10-223 | Ulcerative Colitis | Phase 3 | A Multicenter, Open-Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Ulcerative Colitis |
| M06-808 | Crohn's Disease | CSR.ORG | A Multicenter, Open-Label Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients with Moderate to Severe Crohn's Disease... |
| W15-679 | Spondyloarthritis | Phase 4 | STRIKE – Treating Patients with Early Axial Spondyloarthritis to Target – a 1 Year Randomized Controlled Study Taking an Intense Treatment Approach Versus Routine Treatment |
| P15-776 | Rheumatoid Arthritis | Phase 4 | Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China |
| M11-810 | Hidradenitis Suppurativa (HS) | Phase 3 | A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II |
| P12-598 | Psoriatic Arthritis | PMOS | The Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients with Psoriasis Severe or Moderate with Adalimumab Treatment (TOGETHER) |
| M11-509 | Intestinal Behcet's | Phase 3 | A Multi-Center Study of Adalimumab in Japanese Subjects with Intestinal Behçet's Disease |
| P15-769 | Hidradenitis Suppurativa (HS) | Phase 4 | Effectiveness of Adalimumab in moderate to severe HidrAdenitis SuppuRativa patients - a Multi cOuNtrY study in real life setting - HARMONY Study |
| P15-346 | Ulcerative Colitis | PMOS | A Prospective Multi-Center study to observe the Effectiveness on Ulcerative Colitis and predictive factors of clinical REsponse in Korean Patients treated with Adalimumab (EUREKA study) |
| P16-321 | Crohn's Disease | PMOS | Post-marketing prospective, observational cohort study to evaluate the impact of AbbVie Care patient support program on compliance with adalimumab, patient reported outcomes and health resource utilization in inflammatory bowel diseases, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and psoriasis in Portugal – IMPROVE Study |
| P16-346 | Psoriasis | PMOS | Real-World Outcome of Psoriasis Subjects in Korea on adalimumab |
| M15-573 | Hidradenitis Suppurativa (HS) | Phase 3 | A Phase 3 Multicenter, Open-Label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects with Moderate to Severe Hidradenitis Suppurativa |
| P15-693 | Psoriasis | PMOS | A non-interventional prospective cohort study to provide real-world evidence on the treatment goal achievement rate, adherence to and utilization patterns of adalimumab in patients with moderate to severe plaque psoriasis in Greece-CONCORDIA STUDY |
| P15-696 | Hidradenitis Suppurativa (HS) | PMOS | SOLACE: Canadian Humira® PoSt Marketing Observational EpidemiologicaL Study: Assessing Humira® Real-life EffeCtiveness and Impact on ModeratE to Severe Hidradenitis Suppurativa Burden of Illness and Health Care Resources Utilization |
| P18-839 | Psoriasis | PMOS | Post-marketing surveillance study of adalimumab (Humira®) for hidradenitis suppurativa and pediatric chronic severe plaque psoriasis patients according to the standard for "Re-examination of New Drugs" |
| P16-052 | Hidradenitis Suppurativa (HS) | PMOS | Post-marketing surveillance study of adalimumab (Humira®) for hidradenitis suppurativa and pediatric chronic severe plaque psoriasis patients according to the standard for "Re-examination of New Drugs" |
| P10-446 | Psoriasis | PMOS | Long term Documentation of the Safety and Efficacy as well as the Effects on Work Productivity in Patients with Moderate to Severe Plaque Psoriasis treated with HUMIRA® (Adalimumab) in Routine Clinical Practice (LOTOS) |
| M15-574 | Hidradenitis Suppurativa (HS) | Phase 4 | A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa |
| P15-672 | Ankylosing Spondylitis | PMOS | Prospective, Multi-Center, Observational, Program to Assess Retention Rate, Persistence and Adherence in the Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated with Adalimumab (Humira®) in the Routine Clinical Settings in the Russian Federation |
| P15-759 | Crohn's Disease | PMOS | Assessing Long-term Effectiveness of Adalimumab for treating children and adolescents with Crohn’s disease in real life conditions – LEA |
| M14-033 | Ulcerative Colitis | Phase 3 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis |
| P12-666 | Psoriatic Arthritis | PMOS | Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriatic Arthritis (COMPLETE – PsA) |
| P12-672 | Ankylosing Spondylitis | PMOS | Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (COMPLETE – AS) |
| P15-325 | Ulcerative Colitis | PMOS | Impact of adalimumab on patient-reported outcomes (PROs) in Canadian patients with moderate-to-severe ulcerative colitis (UCanADA): a prospective observational cohort study |
| M11-290 | Ulcerative Colitis | Phase 3 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis |
| M14-115 | Crohn's Disease | Phase 3 | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration |