Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission (UC-GOL)
Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis
This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.
At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.
Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
MI
-
Rozzano、MI、イタリア、20089
- 募集
- IBD Center
-
コンタクト：
- Silvio Danese, MD, PhD
- 電話番号：5555 0039028224
- メール：sdanese@hotmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- patients aged 18-65 years
- ability to understand the study procedures and sign the informed consent
- ulcerative colitis diagnosed at least 6 months before
- no previous exposure to anti-TNFs
- Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
- steroid-dependent disease
- women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation
Exclusion Criteria:
- Crohn's disease or undetermined colitis
- active infections or previous infections not completely resolved at baseline
- malignancies in the previous 5 years
- suspected latent tuberculosis infection
- every other potentially harmful clinical condition, in the opinion of the investigator
- patients with moderately to severe heart failure (NYHA class III/IV)
- hepatic or renal failure
- pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
- not permitted concomitant medications
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：Golimumab
Subcutaneous golimumab
|
Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2) Maintenance regimen:
他の名前：
|
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 |
|---|---|---|
|
clinical and endoscopic steroid-free remission
時間枠：week 16
|
Total Mayo score ≤2, with no sub-score >1.
No concomitant corticosteroid therapy.
|
week 16
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
clinical response
時間枠：week 16
|
Decrease in total Mayo score of at least 2 point and 30 %
|
week 16
|
|
percentage of patients in clinical and endoscopic remission
時間枠：week 52
|
Total Mayo score ≤2, with no sub-score >1
|
week 52
|
|
percentage of patients in clinical remission
時間枠：week 52
|
partial Mayo score ≤2, with no sub-score >1
|
week 52
|
|
percentage of patients with mucosal healing
時間枠：week 16 and 52
|
complete mucosal healing: endoscopic sub-score 0
|
week 16 and 52
|
|
percentage of patients with histological healing
時間枠：week 16 and 52
|
histological healing: Geboes score <3 and no Mayo sub-score >1
|
week 16 and 52
|
|
quality of life
時間枠：week 16 and 52
|
IBDQ questionnaire
|
week 16 and 52
|
|
percentage of infliximab responders
時間枠：week 52
|
week 52
|
|
|
identification of patients that would benefit from golimumab therapy
時間枠：through week 52
|
evaluation of baseline characteristics of patients to identify potential response-predictive factors.
|
through week 52
|
協力者と研究者
捜査官
- スタディチェア：Silvio Danese, MD, PhD、IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。