Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
調査の概要
詳細な説明
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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Chubu Region、日本
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Chugoku Region、日本
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Hokkaido Region、日本
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Kanto Region、日本
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Kinki Region、日本
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Kyushu Region、日本
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Shikoku Region、日本
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Tohoku Region、日本
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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:
Subjects who participated in Study 275-08-003 and meet all of the criteria described below.
- Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.
Exclusion Criteria:
- Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
- Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
- Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
- Patients who required treatment for the same infection at two or more different times during Study 275-08-003
- Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
- Patients whom the investigator has decided to be inappropriate for participation in the study
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: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:Certolizumab pegol 200 mg
Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
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皮下(SC)注射
他の名前:
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実験的:Certolizumab pegol 400 mg
Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
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皮下(SC)注射
他の名前:
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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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Number of Participants With Adverse Events
時間枠:From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
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An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. |
From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
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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 American College of Rheumatology 20% (ACR20) Response
時間枠:Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
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Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
時間枠:Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
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Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
時間枠:Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
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Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Change From Baseline in Disease Activity Score (DAS) 28
時間枠:Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined. The data before study drug administration of 275-08-003 Study was utilized for Baseline. DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. |
Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Change From Baseline in Modified Total Sharp Score (mTSS)
時間枠:Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100
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X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers. The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst). |
Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100
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協力者と研究者
スポンサー
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
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。
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