이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

2012년 8월 1일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

334

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
다른 이름들:
  • 위약
실험적: 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.
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
다른 이름들:
  • ABT-D2E7, 아달리무맙, 휴미라
실험적: 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.
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
다른 이름들:
  • ABT-D2E7, 아달리무맙, 휴미라
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
다른 이름들:
  • 아달리무맙
  • ABT-D2E7
  • 휴미라
실험적: 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.
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
다른 이름들:
  • 위약
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
다른 이름들:
  • 아달리무맙
  • ABT-D2E7
  • 휴미라
실험적: 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.
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
다른 이름들:
  • ABT-D2E7, 아달리무맙, 휴미라
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
다른 이름들:
  • 아달리무맙
  • ABT-D2E7
  • 휴미라
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
다른 이름들:
  • 아달리무맙
  • ABT-D2E7
  • 휴미라
실험적: 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.
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
다른 이름들:
  • 위약
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
다른 이름들:
  • 아달리무맙
  • ABT-D2E7
  • 휴미라
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
다른 이름들:
  • 아달리무맙
  • ABT-D2E7
  • 휴미라

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 연구 책임자: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 3월 1일

기본 완료 (실제)

2011년 3월 1일

연구 완료 (실제)

2011년 8월 1일

연구 등록 날짜

최초 제출

2009년 3월 26일

QC 기준을 충족하는 최초 제출

2009년 3월 26일

처음 게시됨 (추정)

2009년 3월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 8월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 8월 1일

마지막으로 확인됨

2012년 8월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Double-blind Placebo에 대한 임상 시험

3
구독하다