A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
NCT00448383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6610
Last updated 2008-08-04
Summary
This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.
Conditions
Interventions
- BIOLOGICAL
-
40mg every other week
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Beverly Paperiello · Abbott
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-09-30
- Primary Completion
- 2004-11-30
More Related Trials
-
Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
NCT00646386 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
NCT01064856 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
NCT00049751 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis
NCT00233558 ·Status: TERMINATED ·Phase: PHASE4
-
Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
NCT00235859 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
NCT00646178 ·Status: COMPLETED ·Phase: PHASE3
-
A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
NCT01502423 ·Status: COMPLETED ·Phase: PHASE2
-
Long Term Open Label Continuation Study
NCT00195650 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
NCT00235872 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
NCT00443651 ·Status: COMPLETED ·Phase: PHASE3
-
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
NCT00234884 ·Status: COMPLETED
-
Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
NCT00650026 ·Status: APPROVED_FOR_MARKETING
-
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
NCT00235833 ·Status: COMPLETED ·Phase: PHASE2
-
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
NCT00603993 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
NCT00234845 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
NCT00647920 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics
NCT01636817 ·Status: TERMINATED ·Phase: PHASE2
-
Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice
NCT01736189 ·Status: COMPLETED
-
Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis
NCT01163318 ·Status: COMPLETED
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
NCT03823391 ·Status: COMPLETED ·Phase: PHASE2
-
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
NCT01076959 ·Status: COMPLETED
-
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
NCT01166282 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study
NCT02433340 ·Status: COMPLETED ·Phase: PHASE2
-
Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents
NCT01783730 ·Status: COMPLETED
-
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
NCT00647270 ·Status: COMPLETED ·Phase: PHASE3