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-Cilag0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15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 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 corticosteroids 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 0
•- No history of latent or active tuberculosis prior to screening
•- Acceptable evidence of immunity to measles, mumps, rubella, and varicella

•- 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

发起方