A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis in pediatric subjects; MedDRA version: 16.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-004366-18-DE
• Lead Sponsor: Janssen Biologics B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified