A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
2015年6月22日 更新者：Hoffmann-La Roche
A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate.
Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks.
Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks.
Anticipated time on study treatment is 6 months.
調査の概要
研究の種類
介入
入学 (実際)
77
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Graz、オーストリア、8036
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Graz-Eggenberg、オーストリア、8020
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Hollabrunn、オーストリア、2020
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Innsbruck、オーストリア、6020
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Linz、オーストリア、4020
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Salzburg、オーストリア、5020
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Stockerau、オーストリア、2000
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Wels、オーストリア、4600
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Wien、オーストリア、1100
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Wien、オーストリア、1130
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Wien、オーストリア、1160
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Wien、オーストリア、1090
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Wien、オーストリア、1140
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Rheumatoid arthritis of >/= 1 year duration
- Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
- On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
- Body weight </= 150 kg
- Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Functional class IV American College of Rheumatology (ACR) Classification
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Treatment with a biologic agent at any time prior to baseline
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with tocilizumab
- Pregnant or lactating women
- Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- History of or currently active primary or secondary immunodeficiency
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV infection
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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アクティブコンパレータ：A Methotrexate
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15-25 mg orally weekly, Weeks 1-12
15-25 mg orally weekly, Weeks 13-24
8 mg/kg iv every 4 weeks, 24 weeks
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実験的：B Methotrexate Placebo
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15-25 mg orally weekly, Weeks 1-12
15-25 mg orally weekly, Weeks 13-24
8 mg/kg iv every 4 weeks, 24 weeks
methotrexate placebo orally weekly, Weeks 13-24
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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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Change From Week 12 (Randomization) to Week 24 in DAS28
時間枠：Weeks 12 and 24
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The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA).
The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity).
DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)].
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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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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Percentage of Participants With DAS28 Remission at Week 24
時間枠：Week 24
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The DAS28 is a combined index for measuring disease activity in RA.
The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity).
DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS.
DAS28 < 2.6 = remission.
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Week 24
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vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
時間枠：Week 24
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The CDAI is a combined index for measuring disease activity in RA.
CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS.
CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA.
CDAI < 2.8 = remission.
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Week 24
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Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24
時間枠：Week 24
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The SDAI is a combined index for measuring disease activity in RA.
SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL.
CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP.
SDAI < 3.3 = remission.
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Week 24
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Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24
時間枠：Week 24
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The RADAI-5 is a combined index for measuring disease activity in RA.
RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months?
(0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling?
(0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today?
(0 = no pain to 10 = unbearable pain); how would you describe your general health today?
(0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning?
If yes, how long did this stiffness last?
(0 = no stiffness to 10 = stiffness the whole day).
RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5.
RADAI-5 from 0-1.4 = remission.
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Week 24
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Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
時間枠：Weeks 12 and 24
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HAQ-DI scores were obtained by scoring participants' responses to a 20-item questionnaire.
HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do).
The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst).
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score
時間枠：Weeks 12 and 24
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SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire.
SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst).
The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning).
These 8 aspects were summarized as physical and mental component scores.
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores
時間枠：Weeks 12 and 24
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VAS scores were obtained by scoring participants' disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale.
The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity).
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score
時間枠：Week 24
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TSQM scores were obtained by scoring participants' responses to a 14-item questionnaire.
TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.
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Week 24
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年2月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2012年3月12日
QC基準を満たした最初の提出物
2012年4月26日
最初の投稿 (見積もり)
2012年4月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年7月17日
QC基準を満たした最後の更新が送信されました
2015年6月22日
最終確認日
2015年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。