Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
2011年6月17日 更新者：Abbott
A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.
調査の概要
研究の種類
介入
入学 (実際)
88
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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Aichi、日本
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Chiba、日本
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Fukuoka、日本
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Gunma、日本
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Hokkaido、日本
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Hyogo、日本
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Ibaraki、日本
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Kanagawa、日本
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Miyagi、日本
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Nagano、日本
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Okayama、日本
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Osaka、日本
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Saitama、日本
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Shizuoka、日本
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Tokyo、日本
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Toyama、日本
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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
20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:
- Completed Week 36 of Study M03-651 [NCT 00235872]
- Wish to participate in self-injection study
- Give written informed consent
- Comply with protocol requirements
Exclusion Criteria:
- Subject develops serious adverse events at time of eligibility confirmation
- Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
- Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
- The investigator considers the subject inappropriate for participation
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：非ランダム化
- 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：Adalimumab
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT 00235872]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
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40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
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 Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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 |
|---|---|---|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
時間枠：Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
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Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains.
The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Presence of Morning Stiffness by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Duration (Minutes) of the Presence of Morning Stiffness by Visit
時間枠：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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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
捜査官
- スタディディレクター：Shigeki Hashimoto, PhD、Abbott Japan
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
2006年3月1日
一次修了 (実際)
2006年11月1日
試験登録日
最初に提出
2008年1月10日
QC基準を満たした最初の提出物
2008年1月28日
最初の投稿 (見積もり)
2008年1月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年6月21日
QC基準を満たした最後の更新が送信されました
2011年6月17日
最終確認日
2011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。