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

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 9, 2013

Primary Completion Date

February 18, 2015

Study Completion Date

September 1, 2022

Conditions
Colitis, Ulcerative
Interventions
DRUG

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.

Trial Locations (27)

Unknown

Phoenix

Los Angeles

San Francisco

Hartford

Atlanta

Chicago

Rochester

Morristown

Seattle

Graz

Vienna

Brussels

Edmonton

Halifax

Toronto

Aarhus

Hvidovre

Paris

Aachen

München

Beersheba

Haifa

Jerusalem

Nijmegen

Rotterdam

Rzeszow Poland

Warsaw

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01900574 - 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 | Biotech Hunter | Biotech Hunter