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

• Register: EUCTR
• Last refreshed on: 13 July 2020
• Main ID: EUCTR2012-004366-18-AT
• Date of registration: 12/06/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen Biologics B.V.
• Public title: A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely 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 - PURSUIT PEDS PK
• Date of first enrolment: 30/07/2013
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004366-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

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
• 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

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ulcerative Colitis in pediatric subjects
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
CAS Number: 476181-74-5
Current Sponsor code: CNTO148
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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)

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.

Timepoint(s) of evaluation of this end point: See E.5.1

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: See E.5.2

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

Secondary ID(s)

CNTO148UCO1001

Source(s) of Monetary Support

Janssen Research & Development

Ethics review

Status: Approved
Approval date: 30/07/2013
Contact: