Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy

Sponsor
University of Glasgow
Study ID
NCT01021735
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • etanercept or adalimumab — DRUG
    etanercept 50mg/week by s/c injection adalimumab 40mg eow by s/c/ injection
  • Rituximab — DRUG
    1g x2 by IV infusion repeated every 5 months or more

Study Details

That anti-TNF therapy and rituximab therapy are equally effective in treating patients with rheumatoid arthritis who meet the eligibility criteria for biologic therapy in the British Society for Rheumatology guidelines, and have not previously been exposed to biologic therapy.

Key Dates

Start date
Apr 30, 2010
Status verified
May 2015
Primary completion
Dec 31, 2014
Completion
Apr 30, 2015

Study Design

Enrollment
302 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Anti-TNF therapy
    Etanercept or adalimumab by s/c injection
  • Experimental: Rituximab therapy
    Rituximab given by IV infusion

Primary Outcome Measure

Mean change in Disease Activity Score (DAS28) [ Time Frame: 12 months ]

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