Ustekinumab for Intestinal Behçet's Syndrome With Myelodysplastic Syndrome
Efficacy and Safety of Ustekinumab for Intestinal Behçet's Syndrome Complicated by Myelodysplastic Syndrome
調査の概要
詳細な説明
This is a multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of ustekinumab in patients with intestinal Behçet's syndrome complicated by myelodysplastic syndrome (MDS). A total of 8 patients with intestinal Behçet's syndrome and concomitant MDS will be enrolled. Prior to enrollment, all patients will discontinue any previous biologic agents. Ustekinumab will be administered subcutaneously at a dose of 90 mg at weeks 0, 4, and 8, followed by a maintenance dose of 90 mg every 12 weeks (every 3 months). All patients will be followed for a total of 24 months.
Clinical manifestations, inflammatory biomarkers, and endoscopic findings will be documented throughout the study period. Concomitant medications will be recorded, and adverse events will be systematically monitored to evaluate the efficacy and safety of the treatment.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Beijing、中国、100044
- Department of Rheumatology and Immunology, Peking University People's Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Meet the 2014 International Criteria for Behçet's Disease (ICBD) for the diagnosis of Behçet's syndrome; Have a confirmed diagnosis of myelodysplastic syndrome (MDS) by bone marrow aspiration and/or biopsy; Have confirmed intestinal ulcers on colonoscopy; Aged between 18 and 70 years; Have active disease at enrollment, defined as a Behçet's Disease Current Activity Form (BDCAF) score ≥ 1; Provide signed informed consent.
Exclusion Criteria:
Presence of one or more other autoimmune diseases; Involvement of other vital organs (e.g., cardiovascular, neurological) requiring treatment with other biologic agents or high-dose corticosteroids; Receipt of surgical treatment; Severe trilineage cytopenia attributed to myelodysplastic syndrome; Presence of acute or chronic active infection (e.g., bacterial, or viral infections such as EBV, CMV, HIV, or active hepatitis virus) within 4 weeks prior to enrollment; Current or prior history of any malignancy; Pregnancy or within 6 months postpartum; Presence of severe liver failure (Child-Pugh Class C) or end-stage renal disease requiring dialysis.
研究計画
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treated with ustekinumab
Eight patients with intestinal Behçet's syndrome complicated by myelodysplastic syndrome were treated with ustekinumab.
|
Ustekinumab will be administered subcutaneously at a dose of 90 mg at weeks 0, 4, and 8, followed by a maintenance dose of 90 mg every 12 weeks (every 3 months).
|
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 |
|---|---|---|
|
Patients achieving complete remission, marked improvement, and improvement
時間枠：Week 24
|
The primary endpoint was defined as the proportion of patients achieving each response category at week 24.
The response categories included complete remission, marked improvement, and improvement, as defined by the Global Gastrointestinal Symptoms criteria, with the proportion of patients achieving each category expressed as a percentage (%).
|
Week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes of Behcet's Disease Current Activity Form (BDCAF) score of patients
時間枠：Week 24
|
Clinical manifestations are recorded at enrollment and at week 24, and changes in the BDCAF score from baseline to week 24 are evaluated.
The score of BDCAF ranges from 0 to 12, with higher scores indicating greater severity.
|
Week 24
|
|
Changes of Disease Activity Index for Intestinal Behcet's Disease (DAIBD) of patients
時間枠：Week 24
|
Intestinal-related clinical manifestations are documented at enrollment and at week 24.
Changes in the DAIBD score from baseline to week 24 are evaluated.
The score of DAIBD ranges from 0 to 295, with higher scores indicating greater severity.
|
Week 24
|
|
Changes of C-reactive protein
時間枠：Week 24
|
Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.
|
Week 24
|
|
Changes of erythrocyte sedimentation rate
時間枠：Week 24
|
Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
|
Week 24
|
|
Changes of dosage of glucocorticoids from baseline
時間枠：Week 24
|
The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.
|
Week 24
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- Peking University PH
- PAYJ-023 (その他の助成金/資金番号：Bethune-Puai Medical Research Fund)
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。