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

First listed
Mar 16, 2007
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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