このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

2012年8月1日 更新者：Abbott

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

研究の種類

介入

入学 (実際)

334

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

  • 日本
      • Anjo、日本
        • Site Reference ID/Investigator# 46861
      • Aomori、日本
        • Site Reference ID/Investigator# 46919
      • Chiba、日本
        • Site Reference ID/Investigator# 46805
      • Chiba、日本
        • Site Reference ID/Investigator# 46806
      • Chiba、日本
        • Site Reference ID/Investigator# 46880
      • Chiba、日本
        • Site Reference ID/Investigator# 46881
      • Fuchu、日本
        • Site Reference ID/Investigator# 46890
      • Fukuoka、日本
        • Site Reference ID/Investigator# 46902
      • Fukuoka、日本
        • Site Reference ID/Investigator# 46903
      • Fukuoka、日本
        • Site Reference ID/Investigator# 46904
      • Gifu、日本
        • Site Reference ID/Investigator# 46856
      • Gunma、日本
        • Site Reference ID/Investigator# 46944
      • Hiroshima、日本
        • Site Reference ID/Investigator# 46893
      • Hiroshima、日本
        • Site Reference ID/Investigator# 46894
      • Hokkaido、日本
        • Site Reference ID/Investigator# 12161
      • Hokkaido、日本
        • Site Reference ID/Investigator# 46916
      • Hokkaido、日本
        • Site Reference ID/Investigator# 46918
      • Hyogo、日本
        • Site Reference ID/Investigator# 46865
      • Hyogo、日本
        • Site Reference ID/Investigator# 46871
      • Ibaraki、日本
        • Site Reference ID/Investigator# 46801
      • Ibaraki、日本
        • Site Reference ID/Investigator# 46925
      • Iwate、日本
        • Site Reference ID/Investigator# 46800
      • Kagoshima、日本
        • Site Reference ID/Investigator# 46873
      • Kagoshima、日本
        • Site Reference ID/Investigator# 46874
      • Kanagawa、日本
        • Site Reference ID/Investigator# 46845
      • Kanagawa、日本
        • Site Reference ID/Investigator# 46899
      • Kanagawa、日本
        • Site Reference ID/Investigator# 46901
      • Kanazawa、日本
        • Site Reference ID/Investigator# 46851
      • Kanazawa、日本
        • Site Reference ID/Investigator# 46852
      • Kawagoe、日本
        • Site Reference ID/Investigator# 46802
      • Kawasaki、日本
        • Site Reference ID/Investigator# 46900
      • Kirishima、日本
        • Site Reference ID/Investigator# 46875
      • Kitakyushu、日本
        • Site Reference ID/Investigator# 46870
      • Kumamoto、日本
        • Site Reference ID/Investigator# 46872
      • Kumamoto、日本
        • Site Reference ID/Investigator# 46912
      • Kyoto、日本
        • Site Reference ID/Investigator# 46864
      • Maebashi、日本
        • Site Reference ID/Investigator# 46943
      • Matsuyama、日本
        • Site Reference ID/Investigator# 46898
      • Miyazaki、日本
        • Site Reference ID/Investigator# 46915
      • Nagano、日本
        • Site Reference ID/Investigator# 46853
      • Nagano、日本
        • Site Reference ID/Investigator# 46855
      • Nagasaki、日本
        • Site Reference ID/Investigator# 46909
      • Nagasaki、日本
        • Site Reference ID/Investigator# 46910
      • Nagasaki、日本
        • Site Reference ID/Investigator# 46911
      • Nagoya、日本
        • Site Reference ID/Investigator# 46858
      • Nagoya、日本
        • Site Reference ID/Investigator# 46860
      • Nara、日本
        • Site Reference ID/Investigator# 46877
      • Nara、日本
        • Site Reference ID/Investigator# 46885
      • Niigata、日本
        • Site Reference ID/Investigator# 46848
      • Niigata、日本
        • Site Reference ID/Investigator# 46906
      • Oita、日本
        • Site Reference ID/Investigator# 46914
      • Okayama、日本
        • Site Reference ID/Investigator# 46869
      • Okayama、日本
        • Site Reference ID/Investigator# 46886
      • Okayama、日本
        • Site Reference ID/Investigator# 46887
      • Okayama、日本
        • Site Reference ID/Investigator# 46892
      • Okinawa、日本
        • Site Reference ID/Investigator# 46876
      • Osaka、日本
        • Site Reference ID/Investigator# 46946
      • Osaka、日本
        • Site Reference ID/Investigator# 46947
      • Rifu、日本
        • Site Reference ID/Investigator# 46842
      • Sagamihara、日本
        • Site Reference ID/Investigator# 46846
      • Saitama、日本
        • Site Reference ID/Investigator# 46803
      • Saitama、日本
        • Site Reference ID/Investigator# 46804
      • Saitama、日本
        • Site Reference ID/Investigator# 46878
      • Saitama、日本
        • Site Reference ID/Investigator# 46879
      • Sapporo、日本
        • Site Reference ID/Investigator# 46917
      • Shimotsuke、日本
        • Site Reference ID/Investigator# 46942
      • Shizuoka、日本
        • Site Reference ID/Investigator# 46854
      • Shizuoka、日本
        • Site Reference ID/Investigator# 46857
      • Shizuoka、日本
        • Site Reference ID/Investigator# 46859
      • Takamatsu、日本
        • Site Reference ID/Investigator# 46895
      • Tokyo、日本
        • Site Reference ID/Investigator# 46843
      • Tokyo、日本
        • Site Reference ID/Investigator# 46844
      • Tokyo、日本
        • Site Reference ID/Investigator# 46850
      • Tokyo、日本
        • Site Reference ID/Investigator# 46882
      • Tokyo、日本
        • Site Reference ID/Investigator# 46883
      • Tokyo、日本
        • Site Reference ID/Investigator# 46884
      • Tokyo、日本
        • Site Reference ID/Investigator# 46888
      • Tokyo、日本
        • Site Reference ID/Investigator# 46889
      • Tokyo、日本
        • Site Reference ID/Investigator# 46891
      • Tokyo、日本
        • Site Reference ID/Investigator# 46896
      • Toyama、日本
        • Site Reference ID/Investigator# 46849
      • Toyama、日本
        • Site Reference ID/Investigator# 46907
      • Toyoake、日本
        • Site Reference ID/Investigator# 46862
      • Toyohashi、日本
        • Site Reference ID/Investigator# 46866
      • Tsu、日本
        • Site Reference ID/Investigator# 46863
      • Tsukuba、日本
        • Site Reference ID/Investigator# 46926
      • Yokohama、日本
        • Site Reference ID/Investigator# 46897
      • Yokohama、日本
        • Site Reference ID/Investigator# 46905

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

  • Rheumatoid arthritis based on the American College of Rheumatology criteria
  • Methotrexate or leflunomide naïve
  • Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

  • History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
  • Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
  • Joint surgery involving joints to be assessed within 8 weeks prior to Screening

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：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：DB Placebo
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
薬：Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
他の名前：
  • プラセボ
実験的：DB adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
生物学的：Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
他の名前：
  • ABT-D2E7、アダリムマブ、ヒュミラ
実験的：DB Adalimumab/OL Adalimumab
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
生物学的：Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
他の名前：
  • ABT-D2E7、アダリムマブ、ヒュミラ
生物学的：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
他の名前：
  • アダリムマブ
  • ABT-D2E7
  • フミラ
実験的：DB Placebo/OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
薬：Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
他の名前：
  • プラセボ
生物学的：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
他の名前：
  • アダリムマブ
  • ABT-D2E7
  • フミラ
実験的：DB Adalimumab/RE OL Adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
生物学的：Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
他の名前：
  • ABT-D2E7、アダリムマブ、ヒュミラ
生物学的：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
他の名前：
  • アダリムマブ
  • ABT-D2E7
  • フミラ
生物学的：Open-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
他の名前：
  • アダリムマブ
  • ABT-D2E7
  • フミラ
実験的：DB Placebo/RE OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
薬：Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
他の名前：
  • プラセボ
生物学的：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
他の名前：
  • アダリムマブ
  • ABT-D2E7
  • フミラ
生物学的：Open-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
他の名前：
  • アダリムマブ
  • ABT-D2E7
  • フミラ

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
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
時間枠：Baseline, Week 26
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 26

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
時間枠：Week 26
Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
時間枠：Week 26
Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
時間枠：Week 26
Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
時間枠：Baseline, Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 26
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
時間枠：Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 26
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
時間枠：Through Week 26
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.
Through Week 26
Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
時間枠：Baseline, Week 52
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 52
Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
時間枠：Week 52
Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
時間枠：Week 52
Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
時間枠：Week 52
Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
時間枠：Baseline, Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 52
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
時間枠：Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 52
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
時間枠：Through Week 52
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.
Through Week 52

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

Abbott

協力者

Eisai Co., Ltd.

捜査官

  • スタディディレクター：Hiroshi Ukai, BS、Abbott Japan Co.,Ltd

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2009年3月1日

一次修了 (実際)

2011年3月1日

研究の完了 (実際)

2011年8月1日

試験登録日

最初に提出

2009年3月26日

QC基準を満たした最初の提出物

2009年3月26日

最初の投稿 (見積もり)

2009年3月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年8月7日

QC基準を満たした最後の更新が送信されました

2012年8月1日

最終確認日

2012年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • M06-859

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。

購読する