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Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

2011년 6월 17일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

88

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 일본
      • Aichi, 일본
      • Chiba, 일본
      • Fukuoka, 일본
      • Gunma, 일본
      • Hokkaido, 일본
      • Hyogo, 일본
      • Ibaraki, 일본
      • Kanagawa, 일본
      • Miyagi, 일본
      • Nagano, 일본
      • Okayama, 일본
      • Osaka, 일본
      • Saitama, 일본
      • Shizuoka, 일본
      • Tokyo, 일본
      • Toyama, 일본

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:

  • 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

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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
생물학적: Adalimumab
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
다른 이름들:
  • ABT-D2E7
  • 휴미라

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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.
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)

2차 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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
기간: Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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
Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Presence of Morning Stiffness by Visit
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Duration (Minutes) of the Presence of Morning Stiffness by Visit
기간: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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.
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Abbott

협력자

Eisai Co., Ltd.
Abbott Japan Co.,Ltd

수사관

  • 연구 책임자: Shigeki Hashimoto, PhD, Abbott Japan

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

2006년 3월 1일

기본 완료 (실제)

2006년 11월 1일

연구 등록 날짜

최초 제출

2008년 1월 10일

QC 기준을 충족하는 최초 제출

2008년 1월 28일

처음 게시됨 (추정)

2008년 1월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 6월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 6월 17일

마지막으로 확인됨

2011년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • M05-775

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. .

Adalimumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Lebanon

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다