A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT00808509
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    40 mg every other week via subcutaneous injection
  • methotrexate — DRUG
    At least 10 mg/week administered orally or subcutaneously

Study Details

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.

Key Dates

Start date
Jan 31, 2009
Status verified
Nov 2013
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Active Comparator: Adalimumab + MTX
    Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
  • Experimental: Methotrexate
    Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.

Primary Outcome Measure

Percentage of Participants in Remission at Week 28 [ Time Frame: Week 28 ]

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