Clinical trial NCT01230827: A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Official title: A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile Idiopathic Arthritis
golimumab
juvenile arthritis
GO KIDS
anti TNF alpha medications
juvenile psoriatic arthritis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Schering-Plough
First posted: 2010-10-29
Enrollment: 173
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

Detailed description: Approximately 170 juvenile patients will take part in the study worldwide. All patients will receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab subcutaneously (injection under the skin) every 4 weeks from Week 0 through Week 12. At Week 16, patients who have shown at least a 30 percent improvement in their signs and symptoms from when they started the study will be randomized to receive either placebo (sham medicine injection) or 30 mg/m2 of golimumab injections every 4 weeks from week 16 through week 48. If a patient gets markedly worse and is receiving placebo injections, they will be restarted on golimumab at the next scheduled visit and will continue on golimumab. Patients can leave the study at any time without question. Between the Week 48 analyses timepoint to Week 144, which is subsequently amended to Week 248, all patients will receive golimumab 30mg/meter squared, unless, by measurements, they have been nearly cured (clinical remission) by being on placebo, whereby they will be discontinued from the study. Patients may have a change in background treatment after Week 48 based on therapeutic effect. Patients will continue active treatment after Week 48 in a long-term extension until Week 144, which is subsequently amended to Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. Safety will be monitored up to 152 week, which is subsequently amended to 256 weeks including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects).

Eligibility criteria: Inclusion Criteria:

* Diagnosis must have been before the patient's 16th birthday
* Disease duration of at least 6 months before study entry
* Must have 5 or more joints with active arthritis
* Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area \[BSA\] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
* May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
* Must have qualifying laboratory values at the first visit.

Exclusion Criteria:

* Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
* Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
* Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48
timeFrame: Week 16 through Week 48
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48
timeFrame: Week 16 through Week 48
measure: Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48
timeFrame: Week 16 through Week 48
measure: Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48
timeFrame: Week 16 through Week 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Augusta
country: United States
state: Georgia
city: Boston
country: United States
state: Massachusetts
city: Durham
country: United States
state: North Carolina
city: Cincinatti
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Bregenz
country: Austria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Botucatu
country: Brazil
city: Curitiba
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Helsinki
country: Finland
city: Oulu
country: Finland
city: Bad Bramstedt
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Hamburg
country: Germany
city: Sankt Augustin
country: Germany
city: Vilnius
country: Lithuania
city: Ciudad De Mexico
country: Mexico
city: Monterrey
country: Mexico
city: San Luis Potosi
country: Mexico
city: Utrecht
country: Netherlands
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Brunner HI, Ruperto N, Tzaribachev N, Horneff G, Chasnyk VG, Panaviene V, Abud-Mendoza C, Reiff A, Alexeeva E, Rubio-Perez N, Keltsev V, Kingsbury DJ, Del Rocio Maldonado Velazquez M, Nikishina I, Silverman ED, Joos R, Smolewska E, Bandeira M, Minden K, van Royen-Kerkhof A, Emminger W, Foeldvari I, Lauwerys BR, Sztajnbok F, Gilmer KE, Xu Z, Leu JH, Kim L, Lamberth SL, Loza MJ, Lovell DJ, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial. Ann Rheum Dis. 2018 Jan;77(1):21-29. doi: 10.1136/annrheumdis-2016-210456. Epub 2017 May 15.