A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2009
INTERVENTION: investigational material(s) Generic name etc : golimumab INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : SC CONDITION: Ulcerative Colitis PRIMARY OUTCOME: Efficacy,Safety INCLUSION CRITERIA: Have a biopsy consistent with the diagnosis of moderately to severely active ulcerative colitis (UC) prior to the beginning of the trial Must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least 1 of the following therapies: oral 5‐ASAs, oral corticosteroids, 6‐mercaptopurine(6MP) and azathioprine (AZA ) Have or have had a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC)
Epistemonikos ID: 530f422606e0179f2809d4c17933c0955b4f4372
First added on: Aug 26, 2024