A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00448383
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2002
Status verified
Jul 2008
Primary completion
Nov 30, 2004

Study Design

Enrollment
6,610 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Open-label adalimumab

Primary Outcome Measure

Change of disease activity score (DAS28) compared with study entry [ Time Frame: Week 12 ]

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