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
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Drug: Tocilizumab
Drug: Methotrexate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 30
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab
Tocilizumab (8 mg/kg monthly from week 0 to 20)
Drug: Tocilizumab
Tocilizumab (8 mg/kg monthly from week 0 to 20)
Other Names:
  • Roche EU/1/08/492/001
  • ATC code L04AC07
Active Comparator: Methotrexate
MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
Drug: Methotrexate
MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245452

Locations
Belgium
Université Catholique de Louvain
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Patrick Durez
Investigators
Principal Investigator: Patrick DUREZ, Md Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Patrick Durez, Professeur clinique, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01245452     History of Changes
Other Study ID Numbers: P1200/002
Study First Received: November 19, 2010
Last Updated: October 30, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Université Catholique de Louvain:
Rheumatoid arthritis
Tocilizumab
Cardiorespiratory endurance

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014