- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02997605
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients (STAR)
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Bordeaux, 프랑스
- Bordeaux University Hospital
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Brest, 프랑스
- Brest University Hospital
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Cahors, 프랑스
- Jean Rougier Hospital
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Clermont-Ferrand, 프랑스
- Clermont-Ferrand Hospital
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Le Kremlin-Bicêtre, 프랑스
- Bicêtre Hospital
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Lille, 프랑스
- Lille Hospital
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Limoges, 프랑스
- Limoges hospital
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Montpellier, 프랑스
- Montpellier Hospital
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Nice, 프랑스
- Pasteur Hospital
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Orléans, 프랑스
- Orléans Hospital
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Paris, 프랑스
- La Pitié-Salpêtrière
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Paris, 프랑스
- Cochin Hospital
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Paris, 프랑스
- Bichat Hospital
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Pierre-Bénite, 프랑스
- Lyon Sud Hopsital
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Saint-Étienne, 프랑스
- Saint-Etienne Hospital
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Strasbourg, 프랑스
- Strasbourg Hospital
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Toujouse, 프랑스, 31059
- Hospital Pierre-Paul Riquet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients ≥ 18 years old.
- Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
- Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
- Who have been treated with prednisone or prednisolone for at least 6 months.
- With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
- With a DAS28 ≤3.2 for at least 3 months.
- Patients with health insurance
- Patients who have signed a written informed consent form.
Exclusion Criteria:
- Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
- Evidence of a flare within the last 3 months.
- Evidence of an allergy or intolerance to hydrocortisone or prednisone.
- Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
- GC joint injections within the last 3 months or scheduled in the next 3 months.
- Any GC intake expected more than >5mg/day within the next 12 months.
- Association with sultopride and with live vaccines
- Significant trauma or major surgery within the 3 months prior to the baseline visit.
- Scheduled surgery in the next 12 months.
- Fibromyalgia.
- Foreseeable poor compliance with the strategy.
- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- Alcohol and/or drug misuse as determined by the investigator.
- Pregnancy or breastfeeding.
- Patient is not willing to sign the informed consent.
- Juridical Protection
- DAS28>3.2 after one month of a stable dose of prednisone 5 mg/day.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Glucocorticoid (GC) tapering
"GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA).
In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo.
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After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group". After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone.
다른 이름들:
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활성 비교기: Hydrocortisone replacer
"Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation.
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After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group". After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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proportion of patients who could withdraw from prednisone and hydrocortisone at one year
기간: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission.
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one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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proportion of patients who could withdraw from prednisone
기간: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.
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one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
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proportion of patients with acute adrenal insufficiency
기간: one year
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To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.
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one year
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proportion of patients with biological adrenal insufficiency
기간: one year
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To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.
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one year
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proportion of patients needing extra prednisone to control flares
기간: one year
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To compare the proportion of patients needing extra prednisone to control flares
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one year
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proportion of patients who have at least one flare confirmed by the investigator during the protocol.
기간: one year
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To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.
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one year
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area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)
기간: one year
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To compare the area under the curve of the means of the FLARE (Flare Assessment in Rheumatoid Arthritis) at one year with a self-assessment questionnaire.
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one year
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proportion of patients in DAS28 remission and in DAS28 low disease activity
기간: 7 and 12 months
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To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.
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7 and 12 months
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medians of Health Assessment Questionnaire (HAQ)
기간: 4, 7 months and 1 year
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To compare the medians of HAQ at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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medians of Rheumatoid Arthritis Impact of Disease (RAID)
기간: 4, 7 months and 1 year
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To compare the medians of RAID at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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medians of EuroQol 5-dimensional Descriptive system (EQ-5D)
기간: 4, 7 months and 1 year
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To compare the medians of EQ-5D at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)
기간: 4, 7 months and 1 year
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To compare the medians of FACIT-F at 4, 7 months and one year between the groups.
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4, 7 months and 1 year
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proportion of patients with Serious Adverse events
기간: 1 year
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To compare the proportion of patients with Serious Adverse events at one year between the groups.
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1 year
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공동 작업자 및 조사자
수사관
- 연구 의자: Adeline RUYSSEN-WITRAND, MD, PhD, University Hospital of Toulouse, Rheumatology Center
- 연구 의자: Arnaud CONSTANTIN, MD, PhD, University Hospital of Toulouse, Rheumatology Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC31/15/7824
- PHRC (2001/1939)
- 2016-001618-18 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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