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

Sponsor
Patrick Durez
Study ID
NCT01245452
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab (8 mg/kg monthly from week 0 to 20)
  • Methotrexate — DRUG
    MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8

Study Details

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.

Key Dates

Start date
May 31, 2010
Status verified
Oct 2013
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Tocilizumab (8 mg/kg monthly from week 0 to 20)
  • Active Comparator: Methotrexate
    MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8

Primary Outcome Measure

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. [ Time Frame: 2 years ]

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