A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Janssen Biologics B.V.0 个研究点目标入组 125 人开始时间: 2021年6月17日最近更新: 2021年9月7日

研究概览

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•-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 corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency OR required more than 3 courses of corticosteroids in the past year
•-Moderately to severely active UC
•-If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Partecipants 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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

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