Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

Conditions

• Early Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — BIOLOGICAL
• Methotrexate — DRUG
• Adalimumab placebo — BIOLOGICAL
• Methotrexate placebo — DRUG

Study Details

The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

Key Dates

Start date

Dec 31, 2000

Status verified

Jun 2013

Primary completion

Apr 30, 2004

Completion

Apr 30, 2012

Study Design

Enrollment

799 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adalimumab
  Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
• Experimental: Adalimumab + methotrexate
  Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
• Experimental: Methotrexate
  Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.

Primary Outcome Measure

Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 [ Time Frame: Baseline and 52 Weeks ]

Locations (31)

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