Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or Methotrexate Addendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019873-13-BE

Enrollment

Unknown

Registered

2010-04-14

Start date

2010-06-07

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early rheumatoid arthritis MedDRA version: 12.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions

Interventions

Trade Name: RoActemra Product Name: Tocilizumab Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of RA (according to ACR criteria) Disease duration 3.2 with a swollen joint count = 4 MTX naive Stable therapy with corticosteroïds or NSAIDs Presence of knee arthralgia or synovitis (addendum protocol with synovial biopsy). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 1. To analyze the clinical efficacy of Tocilizumab in this population. 2. To correlate the CRE response with other marker (CRP, Hb, DAS, HAQ). 3. To evaluate the safety profile of Tocilizumab. ;Primary end point(s): A work capacity index as a measure of CRE (W65%/kg) expressed in watts per kilograms of body weight and the Borg score, an exertion perception index (0-10) obtained from the heart rate and perceived exertion score during a submaximal gradational cycle ergometer test will be performed at baseline, month 3 and 6. ACR and EULAR core set will be evaluated at every visit by an independent joint articular assessor. The following questionnaire and tests will be performed : HAQ, Abilhand, the anxiety and depression scale (HAD), the Baecke Questionnaire of Habitual Physical Activity. Patients will be randomized according their sex, age and BMI.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 1. To analyze the clinical efficacy of Tocilizumab in this population. 2. To correlate the CRE response with other marker (CRP, Hb, DAS, HAQ). 3. To evaluate the safety profile of Tocilizumab. ;Primary end point(s): A work capacity index as a measure of CRE (W65%/kg) expressed in watts per kilograms of body weight and the Borg score, an exertion perception index (0-10) obtained from the heart rate and perceived exertion score during a submaximal gradational cycle ergometer test will be performed at baseline, month 3 and 6. ACR and EULAR core set will be evaluated at every visit by an independent joint articular assessor. The following questionnaire and tests will be performed : HAQ, Abilhand, the anxiety and depression scale (HAD), the Baecke Questionnaire of Habitual Physical Activity. Patients will be randomized according their sex, age and BMI.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026