2023-507142-83-00已完成3 期
A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
Janssen - Cilag International, Janssen Biologics B.V.5 个研究点 分布在 3 个国家目标入组 7 人开始时间: 2024年7月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Clinical remission as assessed by the Mayo score.
研究概览
简要总结
- To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active UC.
- To evaluate the safety profile of golimumab, in pediatric participants with moderately to severely active UC.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis [UC]) OR required more than 3 courses of D129corticosteroids in the past year
- •Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (>=2)
- •If receiving parenteral or enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week
- •Participants who receive parenteral nutrition are not permitted to enroll in the trial.
- •No history of latent or active tuberculosis prior to screening
- •Acceptable evidence of immunity to measles, mumps, rubella, and varicella
排除标准
- •History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
- •History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- •Have UC limited to the rectum only or to <20 percent (%) of the colon
- •Presence of a stoma
- •Presence or history of a fistula
- •Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information
结局指标
主要结局
Clinical remission as assessed by the Mayo score.
Clinical remission as assessed by the Mayo score.
次要结局
- 1. Clinical response as assessed by the Mayo score.
- 2. Clinical remission as assessed by the PUCAI score.
- 3. Endoscopic healing.
- 4. Clinical remission as assessed by the PUCAI score.
- 5. Endoscopic healing.
- 6. Rémission symtomatologique.
- 7. Clinical remission as assessed by the Mayo score.
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT03596645Janssen Research & Development, LLC84
招募中
3 期
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)Severe AsthmaNCT07276724Generate Biomedicines786
暂停
3 期
A phase III placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in AML patients undergoing allo-HCT (MO-TRANS Study)2024-512752-38-00Priothera S.A.S.104
终止
2 期
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative ColitisColitis, UlcerativeNCT00488774Janssen Research & Development, LLC291
已完成
2 期
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT00487539Janssen Research & Development, LLC1,065