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.
In spite of the improved medical treatment, rheumatoid arthritis (RA) is still causing both significant morbidity and marked loss of work productivity. Short periods of work inability, i.e., sick leaves represent a significant part of the socioeconomic burden of RA. The study is a randomized, controlled double blind multi-center study. 160 patients of 25 to 55 years of age with recent-onset (≤2 years from diagnosis) RA who have been treated with a combination of conventional antirheumatic drugs but have an inadequate response to treatment and are at the risk of losing their ability to work, are enrolled. The patients should be biologic-naïve. Their RA should be active, but not so active that the conventional criteria for biologic therapy would be fulfilled. The subjects are randomized at 1:1 ratio to receive either adalimumab (40 mg every two weeks) or placebo for 6 months added on their concurrent antirheumatic therapy. The RA-related sickness absence and clinical response will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
160
40mg sc. every two weeks for six months
Helsinki University Central Hopsital
Helsinki, Finland
RECRUITINGLappland Central Hospital
Rovaniemi, Finland
RECRUITINGTampere University hospital, Rheumatology Centre
Tampere, Finland
RECRUITINGNumber of lost work days due to RA during the 6-month follow up.
Time frame: 6 months
Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up
Time frame: baseline and 6 months
Change in functionality assessed by the HAQ over the 6-month follow up
Time frame: baseline and 6 months
Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up
Time frame: baseline and 6 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 6 months
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The Turku Universitry Central Hopsital
Turku, Finland
RECRUITING