Ulcerative Colitis in pediatric subjects MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Sponsors
Janssen Biologics B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the PK of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. To evaluate the safety of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. ;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 • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of adverse events up to Week 126 • Physical examination assessments up to Week 126 • Injection-site reactions up to Week 126 • Vital signs assessments up to Week 126 • Clinical laboratory tests up to Week 126 • Early detection of active tuberculosis up to Week 126 • Clinical response at Week 6 • Clinical remission at Week 6 as measured by the Mayo score, which includes stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment • 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. • Mucosal healing at Week 6;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Austria, Belgium, Canada, Denmark, France, Germany, Israel, Netherlands, Poland, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed