Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab; Adalimumab; Placebo; Adalimumab; Adalimumab; Adalimumab
Intervention description: Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.; Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.; Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.; Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.; Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.; Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 619.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of
      adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term
      safety and maintenance of efficacy following repeated administration of adalimumab (during
      open-label extension phase) in patients with persistently active rheumatoid arthritis who
      were receiving concurrent methotrexate therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older and in good health (Investigator discretion) with a recent stable
             medical history

          -  Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid
             arthritis (RA) and had at both screening and baseline visits >=6 swollen joints and
             >=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX).
             (Distal interphalangeal joints [DIPs] were not to be included in joint count for
             inclusion. The screening and baseline visits could be 3 to 28 days apart for patients
             not previously receiving disease-modifying anti-rheumatic drugs [DMARDs] other than
             MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)

          -  Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX
             intolerant).

          -  If patient on a second-line treatment (DMARD) other than MTX, he/she had to
             discontinue it for at least 28 days before the baseline visit (the washout period).

          -  Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin
             per week.

          -  Both rheumatoid factor positivity and a C-reactive protein value >=1 mg/dL, or at
             least one joint erosion on X-ray.

        Exclusion Criteria:

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate
             for the study.

          -  Female subject who was pregnant or breast-feeding or considering becoming pregnant.

          -  Preceding treatment with any tumor necrosis factor (TNF) antagonist, including
             adalimumab.

          -  Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.

          -  Intra-articular, intramuscular, or intravenous administration of corticosteroids
             within 4 weeks prior to the screening visit.

          -  Subject was wheelchair bound or bedridden.