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
- Conditions
- idiopathic chronic inflammatory disease10017969
- Registration Number
- NL-OMON40329
- Lead Sponsor
- Janssen Biologics B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
• 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of this study is to assess PK (eg, serum golimumab<br /><br>concentration at Week 6 and area under the curve from 0 to 6 weeks [AUC0-6<br /><br>weeks]). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Major secondary outcomes include safety through Week 6 and Week 126, as well as<br /><br>clinical response, clinical remission, and mucosal healing, all at Week 6, and<br /><br>Pediatric Ulcerative Colitis Activity Index (PUCAI) remission at Week 54 and<br /><br>Week 110.</p><br>