Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Patrick Durez
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of RA (according to American College of Rheumatology ACR criteria)

• Disease duration < 2 years.

• Age between 18 and 70 years old.

• Active RA defined by a disease activity score 28 DAS28-CRP score > 3.2 with a swollen joint count ≥ 4

• MTX naive

• Stable therapy with corticosteroids or nonsteroidal anti-inflammatory drug NSAIDs

• Presence of knee arthralgia or synovitis (addendum protocol with synovial biopsy).

Exclusion Criteria:

Previous MTX treatment. Exclusion for severe physical handicap to perform CRE. Exclusion for general safety (history of severe allergic reaction, sepsis, malignancy within 5 years, pregnancy, severe heart failure) Concurrent treatment with other DMARDs than MTX or any anti-TNF and biological therapies.