Rheumatoid Arthritis Clinical Trial
Official title:
Comparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate Addendum Protocol : Global Gene Expression Profiles in Synovial Biopsies
To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in
early RA patients treated with tocilizumab compared to Methotrexate alone.
The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population
and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety
profile of Tocilizumab.
Rheumatoid arthritis (RA) is the most prevalent (about 1%) inflammatory rheumatic disorder.
Interleukin-6 (IL-6) has emerged as a potential therapeutic target in RA. This is based on
the greater understanding of the role this cytokine can play in various aspects of the
pathogenesis of RA. It has been shown that IL-6 is responsible for various clinical
symptoms, including,fatigue, anemia, anorexia, fever, as well as the production of
autoantibodies and increase in the erythrocyte sedimentation rate, all of which develop in
patients with RA. Tocilizumab, as monotherapy and in combination with methotrexate, has been
shown to be effective for RA patients with insufficient response to methotrexate or other
disease-modifying antirheumatic drugs. These observations about the effects of tocilizumab
were extended to patients refractory to tumor necrosis factor inhibitors. Tocilizumab also
slows down the progression of structural joint damage. Furthermore, a 5-year long-term
safety and efficacy has been shown. The place of Tocilizumab therapy in early RA is still
unknown.
Cardiorespiratory endurance (CRE), the most fundamental component of physical fitness can be
severely impaired in patients with rheumatoid arthritis (RA). It has been shown that
intensive and early treatment of RA can induce sustained clinical remission, improve general
health and physical fitness and might therefore have an impact on the quality of life of RA
patient. This study was planned to measure the CRE by a work capacity index obtained in a
submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to
Methotrexate alone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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