Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients (STAR)
2022年2月28日 更新者：University Hospital, Toulouse
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
調査の概要
詳細な説明
French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).
研究の種類
介入
入学 (実際)
102
段階
- フェーズ 4
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
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Bordeaux、フランス
- Bordeaux University Hospital
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Brest、フランス
- Brest University Hospital
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Cahors、フランス
- Jean Rougier Hospital
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Clermont-Ferrand、フランス
- Clermont-Ferrand Hospital
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Le Kremlin-Bicêtre、フランス
- Bicetre Hospital
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Lille、フランス
- Lille Hospital
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Limoges、フランス
- Limoges hospital
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Montpellier、フランス
- Montpellier Hospital
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Nice、フランス
- Pasteur Hospital
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Orléans、フランス
- Orléans Hospital
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Paris、フランス
- La Pitié-Salpêtrière
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Paris、フランス
- Cochin Hospital
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Paris、フランス
- Bichat Hospital
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Pierre-Bénite、フランス
- Lyon Sud Hopsital
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Saint-Étienne、フランス
- Saint-Etienne Hospital
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Strasbourg、フランス
- Strasbourg Hospital
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Toujouse、フランス、31059
- Hospital Pierre-Paul Riquet
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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
18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:
- 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.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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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 |
|---|---|---|
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proportion of patients who could withdraw from prednisone and hydrocortisone at one year
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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proportion of patients who could withdraw from prednisone
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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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。
捜査官
- スタディチェア：Adeline RUYSSEN-WITRAND, MD, PhD、University Hospital of Toulouse, Rheumatology Center
- スタディチェア：Arnaud CONSTANTIN, MD, PhD、University Hospital of Toulouse, Rheumatology Center
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 (実際)
2017年1月31日
一次修了 (実際)
2022年1月27日
研究の完了 (実際)
2022年1月27日
試験登録日
最初に提出
2016年12月15日
QC基準を満たした最初の提出物
2016年12月19日
最初の投稿 (見積もり)
2016年12月20日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月2日
QC基準を満たした最後の更新が送信されました
2022年2月28日
最終確認日
2022年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RC31/15/7824
- PHRC (2001/1939)
- 2016-001618-18 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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