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

• Conditions: lcerative Colitis in pediatric subjects; MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-27
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children aged 2 to 17 years of either gender.
• Have moderately to severely active ulcerative colitis (UC), defined as a baseline Mayo score of 6 to 12, inclusive.
• Had UC diagnosed, or was referred to the investigator to establish a diagnosis of UC, at least 2 weeks prior to screening.
• Have the diagnosis of UC confirmed by a previous biopsy (tissue or cell sample) or results from a biopsy conducted at the screening endoscopy procedure that is consistent with a diagnosis of UC.
• Have a Mayo endoscopy subscore = 2 at screening sigmoidoscopy (procedure to examine the large intestine) [indicative of moderately to severely active UC]. A sigmoidoscopy performed within 2 weeks prior to baseline but before informed consent is obtained may be considered the screening sigmoidoscopy if performed by an investigator at the site.
• Prior or current medication for UC must include at least 1 of the following: a) current treatment with at least 1 of the following therapies: oral or intravenous corticosteroids, or the immunomodulators 6-MP or azathioprine (AZA); or b) have a history of failure to respond to or tolerate, or have a medical contraindication to, at least 1 of the following therapies: oral or intravenous corticosteroids or the immunomodulators 6-MP or AZA; or c) currently 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 d) have required more than 3 courses of oral or intravenous corticosteroids in the past year.
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