Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate (TOMERA)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Bruxelles、ベルギー、1200
- Université Catholique de Louvain
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Tocilizumab
Tocilizumab (8 mg/kg monthly from week 0 to 20)
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Tocilizumab (8 mg/kg monthly from week 0 to 20)
他の名前：
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アクティブコンパレータ：Methotrexate
MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
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MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：2 years
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not necessary
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2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To analyze the clinical efficacy of Tocilizumab in this population.
時間枠：2 years
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no necessary
|
2 years
|
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To correlate the CRE response with other marker (CRP, Hb, Disease activity score DAS, HAQ).
時間枠：2 years
|
no necessary
|
2 years
|
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To evaluate the safety profile of Tocilizumab.
時間枠：2 years
|
no necessary
|
2 years
|
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To assess the effect of Tocilizumab on synovial histopathology of early RA
時間枠：2 years
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not necessary
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2 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Patrick Durez, MD、Université Catholique de Louvain
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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