Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis
Remission of rheumatoid arthritis (RA) is an achievable goal with currently available
medications, including the anti-tumor necrosis factor (anti-TNF) agents. However, it is
uncertain if patients with RA in clinical remission while treated with anti-TNF agents and
background disease-modifying antirheumatic drugs (DMARD) would remain in remission if
anti-TNF therapy was stopped. If remission can be sustained off anti-TNF agents, then
patients may be spared the potential toxicity and costs of these medications.
The Stopping Anti-Tumor Necrosis Factor Agents in Rheumatoid Arthritis (STARA) study is a
multicenter, randomized, double-blind, placebo-controlled noninferiority trial that will
test differences in time to relapse between patients with RA in remission who discontinue
anti-TNF agents and patients with RA in remission who continue anti-TNF agents. The
secondary objectives of the study are: 1) to determine if discontinuation of anti-TNF agents
results in a difference in progression of joint damage on radiographs; 2) to determine if
discontinuation of anti-TNF agents results in a difference in physical function, and 3) to
identify predictors of relapse.
Eligible subjects will have RA in remission for at least six months while taking etanercept,
infliximab, or adalimumab. An eight-week run-in period prior to randomization will be used
to confirm remission. Subjects will then be randomized in a 2:1 ratio to receive one of two
blinded treatments: 1) matching placebo or 2) their currently used anti-TNF agent,
respectively. All subjects will maintain their current background DMARD. Clinical
assessments will be performed every 12 weeks. The primary outcome is 48-week relapse-free
status. Secondary outcomes include change from baseline radiographic joint damage score at
48 weeks and 100 weeks, and change from baseline physical function score at 48 weeks.
Subjects who relapse before week 48 will discontinue study medication and receive treatment
through their rheumatologist. Blinded treated will end at week 48 and subjects will be
followed for 52 additional weeks. This study will provide important new information on the
best treatment approach for patients with RA in remission.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Remission by Disease Activity Score - 28 over 48 weeks
Michael M Ward, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
United States: Federal Government
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