Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice
2019년 7월 1일 업데이트: AbbVie (prior sponsor, Abbott)
Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)
This was a single-arm, multicenter, open label, prospective cohort study (post-marketing observational study) to determine the effectiveness and safety of adalimumab in combination with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a routine clinical setting in Japan.
연구 개요
상세 설명
Study assessments occurred at baseline, Week 12, Week 24, Week 52, Week 76, and Week 104.
Most participants received 40 mg of adalimumab every other week during the study.
Two participants started at 40 mg of adalimumab every other week, and increased to 80 mg every other week.
A few participants had a different dose regimen: 40 mg every three weeks for 3 participants; 40 mg every four weeks for 1 participant; and 40 mg every other week with a switch to 50 mg every three weeks for 4 subjects.
연구 유형
관찰
등록 (실제)
346
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
16년 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Participants with rheumatoid arthritis treated in a daily clinical setting, who received adalimumab (and high dose methotrexate [≥12 mg/week]), were observed prospectively.
설명
Inclusion Criteria:
The participants of this study were rheumatoid arthritis (RA) patients for whom adalimumab was prescribed. They must have met the following conditions:
- Disease duration of RA ≤2 years
- Methotrexate (MTX) administration ≥3 months prior to starting adalimumab
- Dose of MTX ≥12mg/week
- Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) score >3.2
Exclusion Criteria:
- Participants who had been previously treated with biologics (including tumor necrosis factor [TNF] inhibitors and others)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Participants treated with adalimumab
40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks
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Pre-filled syringe, administered by subcutaneous injection
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52
기간: At Week 52
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The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hr) or C-reactive protein (CRP; mg/dL) level, and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score.
Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
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At Week 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score ≤ 2.8 at Week 104
기간: At Week 104
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The Clinical Disease Activity Index (CDAI) is a composite index for assessing rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, the participant's global assessment of disease activity (on a visual analog scale [VAS] from 0 to 10 cm), and a physician's global assessment of disease activity (measured on a VAS from 0 to 10 cm) are summed to yield the total score.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Remission is defined as a CDAI score ≤ 2.8.
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At Week 104
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Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score ≤ 3.3 at Week 104
기간: At Week 104
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The SDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
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At Week 104
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Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104
기간: At Week 104
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The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported assessment specific for rheumatoid arthritis.
It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined as HAQ-DI < 0.5.
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At Week 104
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Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104
기간: Baseline and Week 104
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The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3).
EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension.
EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).
Positive numbers indicate improvement from baseline.
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Baseline and Week 104
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Percentage of Participants With a Change From Baseline of ≤ 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104
기간: Baseline and Week 104
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The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage.
X-rays of hands and feet were taken at the visit.
Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation).
Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]).
An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
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Baseline and Week 104
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유용한 링크
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 (실제)
2012년 10월 11일
기본 완료 (실제)
2018년 4월 16일
연구 완료 (실제)
2018년 4월 16일
연구 등록 날짜
최초 제출
2012년 11월 27일
QC 기준을 충족하는 최초 제출
2012년 11월 27일
처음 게시됨 (추정)
2012년 11월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 1일
마지막으로 확인됨
2019년 6월 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. .
류마티스 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
Adalimumab에 대한 임상 시험
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AbbVie (prior sponsor, Abbott)완전한
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Amgen완전한관절염, 류마티스미국, 스페인, 캐나다, 불가리아, 러시아 연방, 독일, 헝가리, 폴란드, 체코 공화국, 루마니아, 영국
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AbbVie (prior sponsor, Abbott)완전한
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University Medical Center Groningen아직 모집하지 않음