Arthritis, Rheumatoid Clinical Trial
Official title:
A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (ADMIRE)
The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate.
Treatments with adalimumab and other tumor necrosis factor (TNF) blockers, once started as
therapy for rheumatoid arthritis (RA), are usually continued indefinitely. Information
concerning the possibility of discontinuing anti-TNF therapy in RA patients who are in
remission is limited. This is a pilot study in one country to study the effect of adalimumab
discontinuation. The objective is to assess the proportion of patients with established RA
in stable remission (Disease Activity Score [DAS]28 <2.6) after treatment with adalimumab in
combination with methotrexate, in whom it is possible to discontinue adalimumab and to
compare the remission rates among patients on sustained therapy with adalimumab +
methotrexate with remission rates among patients who discontinued adalimumab.
Rheumatoid arthritis patients in stable remission (DAS28 < 2.6) treated with adalimumab +
methotrexate were randomized in a 1:1 ratio to continue with adalimumab treatment or
discontinue adalimumab treatment for the following 52 weeks. Subsequently an observational
extension was conducted to observe patients treated at the discretion of the investigator.
The observational extension period lasted until Weeks 105 - 156 (average Week 125) and
consisted of one follow-up visit. Participants randomized to discontinue adalimumab therapy
will be reinstituted to adalimumab if DAS28-score increases by >1.2 units from baseline
and/or is scored ≥2.6 at any visit during the study and will be followed for an additional
12 weeks.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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