REstore Working Ability in RheumatoiD Arthritis

Sponsor
The Rheumatological Center of Helsinki
Study ID
NCT01405326
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    40mg sc. every two weeks for six months

Study Details

The purpose of the study is to assess whether a 6-month treatment with adalimumab added on the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of the intervention compared to the conventional treatment is evaluated, and the patients who benefit most are characterized.

Key Dates

Start date
May 31, 2011
Status verified
Jul 2011
Primary completion
Dec 31, 2012
Completion
Mar 31, 2013

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Experimental: Adalimumab
    Adalimumab treatment for 6 months
  • Placebo Comparator: Pacebo
    Corresponding placebo for active treatment group

Primary Outcome Measure

Number of lost work days due to RA during the 6-month follow up. [ Time Frame: 6 months ]

Central Contacts

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