A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

Who is this study for? Child to young adult patients with Juvenile Idiopathic Arthritis
What treatments are being studied? Golimumab
Status: Completed
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (\>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for \>= 2 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• Diagnosis must be made per Juvenile Idiopathic Arthritis (JIA) International League of Associations for Rheumatology (ILAR) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday

• Failure or inadequate response to at least a 2 month course of methotrexate (MTX) before screening

• Participants must have greater than or equal to (\>=) 5 joints with active arthritis at screening and at Week 0 as defined by American College of Rheumatology (ACR) criteria (that is, a joint with either swelling, or in the absence of swelling, limited range of motion associated with pain on motion or tenderness)

• Participants must have a screening C-reactive protein (CRP) of \>=0.1 milligram (mg)/deciliter (dL) with the exception of approximately 30 percent (%) of the study population

• Participants must have active polyarticular juvenile idiopathic arthritis (pJIA) despite current use of oral, intramuscular, or subcutaneous MTX for \>=2 months before screening. For participants with body surface area (BSA) less than (\<)1.67 meter square (m\^2), the MTX dose must be between 10 to 30 milligram per meter square (mg/m\^2) per week and stable for \>=4 weeks before screening. For participants with BSA \>=1.67 m\^2, the MTX dose must be a minimum of 15 mg/week and must be stable for \>=4 weeks before screening. In situations where there is documented intolerance of doses greater than (\>)10 mg/m\^2 weekly (for participants with BSA \<1.67 m\^2) or \>=15 mg/week (for participants with BSA \>=1.67 m\^2); or where documented country or site regulations prohibit use of \>=15 mg of MTX per week in participants with BSA \>=1.67 m\^2, participants may be entered into the trial on a lower dose of MTX

Locations
United States
California
San Diego
Illinois
Chicago
Massachusetts
Boston
North Carolina
Durham
Hickory
New Jersey
Hackensack
New York
New Hyde Park
Ohio
Avon
Cincinnati
Cleveland
Oregon
Portland
Pennsylvania
Philadelphia
Texas
Austin
Utah
Salt Lake City
Other Locations
Argentina
Buenos Aires
Rosario
San Miguel De Tucumán
Brazil
Botucatu
Campinas
Porto Alegre
Rio De Janeiro
São Paulo
Canada
Calgary
Montreal
Toronto
Chile
Región Metropolitana De Santia
Israel
Haifa
Kfar Saba
Petah Tikva
Mexico
Chihuahua City
Guadalajara
Mexico City
Russian Federation
Mosco2
Saint Petersburg
Saratov
Tolyatti
Ufa
South Africa
Cape Town
Time Frame
Start Date: 2014-12-22
Completion Date: 2024-09-27
Participants
Target number of participants: 130
Treatments
Experimental: Golimumab + Methotrexate
Participants will receive 80 milligram per meter square (mg/m\^2) as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks thereafter up to Week 244, along with commercial methotrexate (MTX) weekly through Week 28 at the same Body Surface Area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square (m\^2), or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at the time of study entry. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m\^2 every 8 weeks after completion of the Week 252 assessments.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov