A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK

Janssen Biologics B.V.0 sites30 target enrollmentStarted: June 12, 2013Last updated: July 13, 2020

Conditions

Trial Snapshot

No summary available.

•Moderate to severe Ulcerative Colitis (UC) defined by a Mayo score (a score used to assess the treatment for UC) of 6 to 12 inclusive, including an endoscopic subscore of 2 or more.
•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 and azathioprine OR
•must either have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC) OR
•required more than 3 courses of corticosteroids in the past year
•No history of latent or active tuberculosis prior to screening
•Positive protective antibody titers to varicella and measles prior to the first administration of study agent
•Have severe extensive UC that is likely to require a colectomy (surgical removal of the colon) within 12 weeks of study entry
•Have UC limited to the rectum only or to less than 20 cm of the colon
•Presence of a stoma
•Presence or history of a fistula
•Have evidence of Crohn's disease (an inflammatory large intestine disease)
•Previous exposure to anti-tumor necrosis factor therapy
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•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

•Have severe extensive colitis as evidenced by investigator judgment that the participant is likely to require a colectomy within 12 weeks of baseline; or symptom complex at screening or baseline visits that includes at least 4 of the following: 1) diarrhea with = 6 bowel movements/day with macroscopic blood in stool; 2) focal severe or rebound abdominal tenderness; 3) persistent fever (= 37.5°C); 4) tachycardia (> 90 beats/minute); or 5) anemia (hemoglobin < 8.5 g/dL).
•Have UC limited to the rectum only or to < 20 cm of the colon.
•Presence of a stoma (a medical opening in the abdomen).
•Presence or history of a fistula (an abnormal passageway between two organs of the body).
•Have severe, fixed symptomatic stenosis (narrowing) of the large or small intestine.

Sponsor