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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Durez, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01245452
First received: November 19, 2010
Last updated: October 30, 2013
Last verified: October 2013

November 19, 2010
October 30, 2013
May 2010
June 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
not necessary
Same as current
Complete list of historical versions of study NCT01245452 on ClinicalTrials.gov Archive Site
  • To analyze the clinical efficacy of Tocilizumab in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    no necessary
  • To correlate the CRE response with other marker (CRP, Hb, Disease activity score DAS, HAQ). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    no necessary
  • To evaluate the safety profile of Tocilizumab. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    no necessary
  • To assess the effect of Tocilizumab on synovial histopathology of early RA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    not necessary
  • To analyze the clinical efficacy of Tocilizumab in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    no necessary
  • To correlate the CRE response with other marker (CRP, Hb, DAS, HAQ). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    no necessary
  • To evaluate the safety profile of Tocilizumab. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    no necessary
Not Provided
Not Provided
 
Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Tocilizumab
    Tocilizumab (8 mg/kg monthly from week 0 to 20)
    Other Names:
    • Roche EU/1/08/492/001
    • ATC code L04AC07
  • Drug: Methotrexate
    MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
  • Experimental: Tocilizumab
    Tocilizumab (8 mg/kg monthly from week 0 to 20)
    Intervention: Drug: Tocilizumab
  • Active Comparator: Methotrexate
    MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
    Intervention: Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
June 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01245452
P1200/002
No
Patrick Durez, Université Catholique de Louvain
Patrick Durez
Not Provided
Principal Investigator: Patrick DUREZ, Md Université Catholique de Louvain
Université Catholique de Louvain
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP