Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis
2021年11月12日 更新者：Dr. Peter Mandl、Medical University of Vienna
Screening for Flare After Discontinuation of Biological/Targeted Synthetic Disease Modifying Anti-rheumatic Drug (b/tsDMARD) in Rheumatoid Arthritis
To evaluate whether stringent follow-up consisting of combined laboratory and ultrasound surveillance is superior to clinical monitoring alone to maintain clinical remission in rheumatoid arthritis.
調査の概要
状態
まだ募集していません
条件
詳細な説明
Randomized, controlled, parallel-group, multi-centre study in which patients with rheumatoid arthritis treated with biological/targeted synthetic disease modifying antirheumatic drug (b/tsDMARD) in mono- or combination therapy with conventional synthetic disease modifying antirheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months with low disease activity or remission will receive an power Doppler musculoskeletal ultrasound examination (PDUS) and monitoring of C-reactive protein (CRP) levels at baseline and several timepoints within a 24 month study period (primary endpoint) and within a 48 month long-term extension.
At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.
Further stratification for remission vs. low disease activity and mono- vs combination therapy will be implemented in the randomisation process.
In arm A, CRP and PDUS information will be made available to the clinical assessors who, at each time-point will use this information along with that from clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.
In arm B the results of CRP and PDUS will be recorded but will not be made available to the clinical assessor who will have to identify clinical flares according to predefined criteria based on information from the clinical examination only.
研究の種類
介入
入学 (予想される)
85
段階
- 適用できない
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 with rheumatoid arthritis classified by the American College of Rheumatology/European League Against Rheumatism classification criteria
- biological disease-modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) treatment in monotherapy or in combination therapy with conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months. Previous extension of bDMARD or tsDMARD interval will also be accepted. bDMARDs and tsDMARDs will include all currently available originator and biosimilar compounds, with the exception of rituximab and its biosimilar compounds
- No swollen joint by 28-joint count at baseline, and screening
- C-reactive protein of ≤0.5mg/dL at baseline AND history of C-reactive protein >0,5mg/dl related to rheumatoid arthritis activity
- Clinical disease activity index ≤10
- Shared decision between patient and physician to attempt b/tsDMARD withdrawal
- Willing and able to understand and follow the study procedures
- Written informed consent
- Female and male subjects aged ≥ 18 years
Exclusion Criteria:
- History of or current extra-articular manifestation of rheumatoid arthritis, with exception of rheumatoid nodules
- Systemic glucocorticoid treatment in the past 3 months
- Intraarticular injection with glucocorticoids in the past 1 month
- Joint replacement surgery other than total knee or hip arthroplasty or complete joint destruction
- Power Doppler signal ≥2 in any assessed joint and/or tendon at screening or baseline
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Assisted monitoring
In the Assisted monitoring arm, C-reactive protein and musculoskeletal ultrasound information will be made available to the clinical assessors who, at each time-point will use this information, along with information from the clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.
|
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
他の名前：
|
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他の：Clinical monitoring
In the Clinical monitoring arm, the results of C-reactive protein and musculoskeletal ultrasound information will be recorded but will not be made available to the clinical assessor who at each time-point will make the decision on whether the patient is experiencing or has experienced a clinical flare according to predefined criteria based on information from the clinical examination.
|
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
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 |
|---|---|---|
|
Proportion of subjects without a clinical flare until week 24
時間枠：week 24
|
Proportion of subjects without a clinical flare
|
week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of subjects without a clinical flare
時間枠：week 48
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Proportion of subjects without a clinical flare
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week 48
|
|
Time to clinical flare (days)
時間枠：study period
|
Time to clinical flare (days)
|
study period
|
|
28 swollen joint count
時間枠：week 24
|
28 swollen joint count, scale 0 (best) - 28 (worse)
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week 24
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28 tender joint count
時間枠：week 24
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28 tender joint count, scale 0 (best) - 28 (worse)
|
week 24
|
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Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation
時間枠：week 24
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Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation
|
week 24
|
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Proportion of patients in low disease activity or remission based on simplified disease activity index
時間枠：week 24
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Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 24
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Proportion of patients in low disease activity or remission based on simplified disease activity index
時間枠：week 48
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Proportion of patients in low disease activity or remission based on simplified disease activity index
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week 48
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Patient's global assessment
時間枠：week 24
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Patient's global assessment, scale 0 (best) - 100 (worst)
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week 24
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Evaluator's global assessment
時間枠：week 24
|
Evaluator's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
C-reactive protein
時間枠：week 24
|
C-reactive protein, scale 0 (best) - infinite (worst)
|
week 24
|
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Radiographic progression
時間枠：at week 48 weeks from baseline
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change in Sharp Van der Heijde score, scale 0 (best) - 488 (worse)
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at week 48 weeks from baseline
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Health Assessment Questionnaire Disability Index
時間枠：week 24
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Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)
|
week 24
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World Health Organization Quality of Life Questionnaire
時間枠：week 24
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World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)
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week 24
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Morning stiffness
時間枠：week 24
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Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)
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week 24
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Fatigue
時間枠：week 24
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Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)
|
week 24
|
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。
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 (予想される)
2022年3月1日
一次修了 (予想される)
2024年9月1日
研究の完了 (予想される)
2024年9月1日
試験登録日
最初に提出
2021年11月2日
QC基準を満たした最初の提出物
2021年11月12日
最初の投稿 (実際)
2021年11月15日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月15日
QC基準を満たした最後の更新が送信されました
2021年11月12日
最終確認日
2021年11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
- 1389/2020
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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