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 subjectsMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-004366-18-AT
- Lead Sponsor
- Janssen Biologics B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the PK of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.<br><br>To evaluate the safety of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.<br>;Secondary Objective: To evaluate the efficacy of golimumab induction (ie, short-term therapy) in pediatric subjects aged 2 through 17 years with moderately to severely active UC.;Primary end point(s): • Serum golimumab concentration at Week 6<br>• Area under the curve (of serum concentrations) for golimumab from Week 0 to Week 6 (AUC0-6 weeks);Timepoint(s) of evaluation of this end point: See E.5.1
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Number of adverse events up to Week 126<br>• Physical examination assessments up to Week 126<br>• Injection-site reactions up to Week 126<br>• Vital signs assessments up to Week 126<br>• Clinical laboratory tests up to Week 126<br>• Early detection of active tuberculosis up to Week 126<br>• Clinical response at Week 6 <br>• Clinical remission at Week 6 as measured by the Mayo score, which includes stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment<br>• Pediatric Ulcerative Colitis Activity Index (PUCAI) remission up to Week 110. The PUCAI score includes abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level.<br>• Mucosal healing at Week 6;Timepoint(s) of evaluation of this end point: See E.5.2