A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT01900574
• Date of registration: 12/07/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
• Scientific title: 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
• Date of first enrolment: August 9, 2013
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01900574
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Austria, Belgium, Canada, Denmark, France, Germany, Israel, Netherlands, Poland, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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

Exclusion criteria:

- 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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Golimumab

Primary Outcome(s)

Serum golimumab concentrations at Week 6 [Time Frame: Week 6]

Secondary Outcome(s)

Number of participants with mucosal healing at Week 6 [Time Frame: Week 6]

Number of participants who will achieve clinical remission at Week 54 and Week 110 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score [Time Frame: Week 54 and Week 110]

Number of participants who will achieve clinical response at Week 6 [Time Frame: Week 6]

Number of participants who will achieve clinical remission at Week 6 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score [Time Frame: Week 6]

Number of participants who will achieve clinical remission at Week 6 measured by the Mayo score [Time Frame: Week 6]

Secondary ID(s)

CNTO148UCO1001

2012-004366-18

CR101676

Source(s) of Monetary Support

Please refer to primary and secondary sponsors