A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) (REGAIN)
This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in 28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.
To be eligible for participation, subjects must have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, who have since exhibited a diminished response despite continued treatment. It is estimated that 200 subjects will be enrolled in the study at approximately 85 global sites.
調査の概要
詳細な説明
The study employs an open-label "active switch" design that moves subjects from infliximab to golimumab 2 mg/kg IV. In general, subjects eligible for the study include men or women who are currently receiving infliximab in actual clinical practice who are at least 18 years of age with active rheumatoid arthritis, and have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, but now exhibit a diminished response and inadequate disease control despite continued treatment. Subjects must have received infliximab in combination with methotrexate for a minimum of 9 months prior to the first screening visit.
The screening visit will occur sometime between Week -12 and Week -10. Consenting subjects who meet screening criteria will receive their final dose of infliximab at Week -8 as part of actual clinical practice. Golimumab IV treatment, which will be supplied by the sponsor, will be received at Weeks 0, 4, 12, 20, and 28. The primary endpoint is at Week 24, the final efficacy assessment is at Week 32, and a follow-up safety assessment by telephone is at Week 44. There will be a maximum of 36 weeks between the last infliximab infusion at Week -8 and the last infusion of golimumab at Week 28. The duration of study participation is expected to be a maximum of 56 weeks (including the Screening Period, 32 weeks of golimumab treatment and assessment, and a 12-week safety follow-up).
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ
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Huntsville、Alabama、アメリカ
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Arizona
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Peoria、Arizona、アメリカ
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Phoenix、Arizona、アメリカ
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Arkansas
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Fort Smith、Arkansas、アメリカ
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California
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Fremont、California、アメリカ
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Fullerton、California、アメリカ
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Long Beach、California、アメリカ
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Santa Maria、California、アメリカ
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Thousand Oaks、California、アメリカ
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Whittier、California、アメリカ
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Connecticut
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Bridgeport、Connecticut、アメリカ
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Florida
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Clearwater、Florida、アメリカ
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Miami、Florida、アメリカ
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Orlando、Florida、アメリカ
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Sarasota、Florida、アメリカ
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Tampa、Florida、アメリカ
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Idaho
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Coeur D'Alene、Idaho、アメリカ
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Indiana
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Indianapolis、Indiana、アメリカ
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South Bend、Indiana、アメリカ
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Minnesota
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Eagan、Minnesota、アメリカ
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Edina、Minnesota、アメリカ
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Missouri
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Saint Louis、Missouri、アメリカ
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New Mexico
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Albuquerque、New Mexico、アメリカ
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New York
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Orchard Park、New York、アメリカ
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North Carolina
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Asheville、North Carolina、アメリカ
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Charlotte、North Carolina、アメリカ
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Greensboro、North Carolina、アメリカ
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Hickory、North Carolina、アメリカ
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Wilmington、North Carolina、アメリカ
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Ohio
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Dayton、Ohio、アメリカ
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Pennsylvania
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Duncansville、Pennsylvania、アメリカ
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Philadelphia、Pennsylvania、アメリカ
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Pittsburgh、Pennsylvania、アメリカ
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Wyomissing、Pennsylvania、アメリカ
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South Carolina
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Charleston、South Carolina、アメリカ
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Columbia、South Carolina、アメリカ
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Myrtle Beach、South Carolina、アメリカ
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Tennessee
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Hixson、Tennessee、アメリカ
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Jakson、Tennessee、アメリカ
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Nashville、Tennessee、アメリカ
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Texas
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Houston、Texas、アメリカ
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Plano、Texas、アメリカ
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San Antonio、Texas、アメリカ
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Virginia
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Arlington、Virginia、アメリカ
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Washington
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Spokane、Washington、アメリカ
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Wisconsin
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Glendale、Wisconsin、アメリカ
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Rimouski、カナダ
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British Columbia
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Victoria、British Columbia、カナダ
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Newfoundland and Labrador
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Saint-John'S、Newfoundland and Labrador、カナダ
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St. John'S、Newfoundland and Labrador、カナダ
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Ontario
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Hamilton、Ontario、カナダ
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Quebec
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Montreal、Quebec、カナダ
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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
Major Inclusion Criteria include (but not limited to):
- Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of the American Rheumatism Association).
- Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).
- Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR) at Week -8 and Week 0.
- Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at Week 0.
- Prior response confirmed by physician.
Major Exclusion Criteria include (but not limited to):
- Have a history of latent or active granulomatous infection, including histoplasmosis, or Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during the Screening Period.
- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
- Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.
- Have previously received more than 1 of the currently approved subcutaneous (SC) administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or adalimumab.
- Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
- Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242 pounds).
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Golimumab 2 mg/kg IV
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
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Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
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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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Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
時間枠：Week 24
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The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas.
The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).
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Week 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 Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
時間枠：Week 24
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The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas.
The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
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Week 24
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Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
時間枠：Week 24
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The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas.
The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
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Week 24
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協力者と研究者
スポンサー
出版物と役立つリンク
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 (実際)
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
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。
Golimumab 2 mg/kg IVの臨床試験
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Rockefeller UniversityBrigham and Women's Hospital; Weill Medical College of Cornell University; University of Cologne完了
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BioMarin Pharmaceutical終了しました
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BioMarin Pharmaceutical終了しました
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Bristol-Myers Squibb完了メラノーマフランス, カナダ, アメリカ, ドイツ, オーストラリア, ロシア連邦, スペイン, イタリア, オランダ, ポーランド, デンマーク, イスラエル, イギリス
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Regeneron Pharmaceuticals完了
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Janssen-Cilag Ltd.完了クローン病アメリカ, 大韓民国, オランダ, フランス, オーストリア, イタリア, イギリス, ドイツ, ロシア連邦, スペイン, チェコ, スウェーデン