Status:
COMPLETED
Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate
Lead Sponsor:
Patrick Durez
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
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 unde...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01245452
Start Date
May 1 2010
End Date
June 1 2013
Last Update
October 31 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Université Catholique de Louvain
Brussels, Belgium, 1200