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

NCT ID: NCT01900574

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-09
• Study Completion Date: 2022-09-01

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

Detailed Description

This is an open-label (both [participants and investigator] know what treatment participants will receive) and multicenter study. The study is divided into 2 parts: Part 1: pharmacokinetics portion (Week 0 to Week 14); Part 2: study extension (Week 14 to Week 114). The focus of this study is to evaluate the pharmacokinetics and safety of golimumab. Additionally the efficacy of short-term therapy with golimumab will be evaluated. Participants in clinical response at Week 6 will continue to receive open label golimumab maintenance therapy and will enter the study extension at Week 14. Participants who are not in clinical response at Week 6 will be withdrawn from further treatment with golimumab. At Week 114, participants who, in the opinion of the investigator, may benefit from continued treatment will be eligible to continue to receive golimumab every 4 weeks until marketing authorization is obtained in the treatment of pediatric UC in that country, or until a decision has been made not to pursue an indication in pediatric UC. Approximately 30 participants will be enrolled in this study. The total duration of study participation for a participant will be approximately 126 weeks or longer.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Golimumab

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

Golimumab will be administered subcutaneously. For participants weighing less than 45 kg, the dose of golimumab at Week 0 will be 90 mg/m2 (up to 200 mg) and 45 mg/m2 (up to 100 mg) at Weeks 2, 6, and 10. For participants weighing 45 kg or more, the dose of golimumab at Week 0 will be 200 mg and 100 mg at Weeks 2, 6, and 10. From Week 14, the dose of golimumab will be 45 mg/m2 and 100 mg, every 4 weeks for participants weighing less than 45 kg and 45 kg or more, respectively. From Week 18, participants weighing 45 kg or more have the option to administer golimumab at home after being properly trained. At Week 14 or at any time after, the participants have the option to decrease their dose of golimumab to 50 mg (weighing 45 kg or more) or 22.5 mg/square meter (less than 45 kg) at the discretion of the investigator. A single dose increase back to 100 mg or 45 mg/m2 is permitted based on the investigator's assessment of an increase in a participant's ulcerative colitis disease activity.

Interventions

Golimumab

Golimumab will be administered subcutaneously. For participants weighing less than 45 kg, the dose of golimumab at Week 0 will be 90 mg/m2 (up to 200 mg) and 45 mg/m2 (up to 100 mg) at Weeks 2, 6, and 10. For participants weighing 45 kg or more, the dose of golimumab at Week 0 will be 200 mg and 100 mg at Weeks 2, 6, and 10. From Week 14, the dose of golimumab will be 45 mg/m2 and 100 mg, every 4 weeks for participants weighing less than 45 kg and 45 kg or more, respectively. From Week 18, participants weighing 45 kg or more have the option to administer golimumab at home after being properly trained. At Week 14 or at any time after, the participants have the option to decrease their dose of golimumab to 50 mg (weighing 45 kg or more) or 22.5 mg/square meter (less than 45 kg) at the discretion of the investigator. A single dose increase back to 100 mg or 45 mg/m2 is permitted based on the investigator's assessment of an increase in a participant's ulcerative colitis disease activity.

Intervention Type: DRUG

Other Intervention Names

Simponi

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Phoenix, Arizona, United States

Los Angeles, California, United States

San Francisco, California, United States

Hartford, Connecticut, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Rochester, Minnesota, United States

Morristown, New Jersey, United States

Seattle, Washington, United States

Graz, , Austria

Vienna, , Austria

Brussels, , Belgium

Edmonton, Alberta, Canada

Halifax, Nova Scotia, Canada

Toronto, Ontario, Canada

Aarhus, , Denmark

Hvidovre, , Denmark

Paris, , France

Aachen, , Germany

München, , Germany

Beersheba, , Israel

Haifa, , Israel

Jerusalem, , Israel

Nijmegen, , Netherlands

Rotterdam, , Netherlands

Rzeszow Poland, , Poland

Warsaw, , Poland

Countries

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

Other Identifiers

CNTO148UCO1001

Identifier Type: OTHER

Identifier Source: secondary_id

2012-004366-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR101676

Identifier Type: -

Identifier Source: org_study_id