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) |
| 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 |
| 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 |
| HUM 03-1 | Rheumatoid Arthritis | PMOS | Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| P12-768 | Ankylosing Spondylitis | PMOS | Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis |
| 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… |
| 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 |
| P12-070 | Rheumatoid Arthritis | PMOS | Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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)) |
| 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 |
| P10-147 | Ankylosing Spondylitis | PMOS | Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice |
| 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. |
| 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 |
| P13-683 | Rheumatoid Arthritis | PMOS | Physical Activity in Patients with Rheumatoid Arthritis Treated with Adalimumab 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) |
| 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. |
| 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 |
| 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) |
| 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 |
| 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 |
| 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… |
| 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 |
| 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 |
| 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 |
| 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 |
| M02-575 | 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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... |
| 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… |
| 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… |
| 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... |
| M02-573 | Rheumatoid Arthritis | CSR.ORG | A Randomized, Double-Blind, Placebo-Controlled, Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Inj... |
| 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 |
| 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… |
| 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… |
| 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 |
| 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 |
| 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… |
| 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... |
| 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 |
| M05-770 | Rheumatoid Arthritis | Phase 2 | Trial of Usability in Clinical Settings of the Humira Autoinjector vs Pre-filled Syringe (TOUCH) |
| 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 |
| DE018 | Rheumatoid Arthritis | CSR.ORG | A Multi-center Open-Label Continuation Study with Subcutaneous D2E7 for Patients with Rheumatoid Arthritis Who Completed a Precedi… |
| 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 |
| M03-583 | 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 |
| 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… |
| 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… |
| 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… |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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… |
| 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… |
| M02-575 | Rheumatoid Arthritis | CSR.ORG | A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose-Ranging Study of Subcutaneously Administered A… |
| 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)… |
| 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 |
| 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) |
| 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 |
| 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 |
| M10-238 | Psoriasis | Phase 3 | Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy |
| 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... |
| 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... |
| 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) |
| 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 |
| 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) |
| 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 |
| W13-984 | Ankylosing Spondylitis | Phase 4 | Rapidity of onset of response to adalimumab in luminal Crohn's disease. RAPIDA study |
| 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 |
| P15-084 | Psoriatic Arthritis | PMOS | Special Investigation (Working Productivity and Activity Impairment in Japanese Patients with Psoriatic Arthritis) |
| W14-406 | Psoriasis | Phase 3 | Concomitant longitudinal evaluation of adalimumab with methotrexate in the real world: the CLEAR study |
| 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 |
| P14-152 | Intestinal Behcet's | PMOS | Humira® 40mg Syringe 0.8mL Subcutaneous Injection. Special Investigation in Patients With Intestinal Behcet's Disease |
| 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) |
| P15-619 | Crohn's Disease | PMOS | Post-Marketing Surveillance of Humira Injection in Korean Pediatric CD Patients under the "New-Drug Re-examination" |
| 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 |
| 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 |
| M14-193 | Psoriasis | Phase 3 | A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects with Generalized Pustular Psoriasis |