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)

NCT01230827 | Terminated Phase 3 Results DMC

• 3 other identifiers: CR017089CNTO148JIA30012009-015019-42
• Study Type: interventional
• Target: 173
• Locations: 12 countries
• Sites: 35

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile Idiopathic Arthritis; golimumab; juvenile arthritis; GO KIDS; anti TNF alpha medications; juvenile psoriatic arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.

  Week 16 through Week 48

Secondary Outcomes (3)

• Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48

  Week 16 through Week 48

• Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48

  Week 16 through Week 48

• Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48

  Week 16 through Week 48

Study Arms (2)

CNTO 148 (Golimumab)

EXPERIMENTAL

All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response at Week 16 and who are randomly allocated to golimumab, will receive 30 mg per square meter every 4 weeks through Week 48. Patients will continue to receive golimumab 30 mg per square meter after Week 48 in a long-term extension until Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration.

Drug: CNTO 148 (Golimumab); Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive placebo every 4 weeks through Week 48. However, patients receiving placebo and who will have lack/loss of clinical response will be eligible to receive golimumab 30 mg per square meter every 4 weeks through Week 48. At Week 48, patients do not have a clinical response will begin to receive golimumab 30 mg per square meter in a long-term extension until Week 248 and patients who have a clinical response will be discontinued from the study. All patients will receive their fixed dose of commercial methotrexate throughout the study duration.

Drug: Placebo; Drug: Methotrexate

Interventions

CNTO 148 (Golimumab) DRUG

Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248.

CNTO 148 (Golimumab)

Placebo DRUG

Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48.

Placebo

Methotrexate DRUG

All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.

CNTO 148 (Golimumab); Placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Schering-Plough: collaborator

Study Sites (35)

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Los Angeles, California, United States

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San Francisco, California, United States

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Augusta, Georgia, United States

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Boston, Massachusetts, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Bregenz, Austria

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Vienna, Austria

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Botucatu, Brazil

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Curitiba, Brazil

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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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Halifax, Nova Scotia, Canada

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Toronto, Ontario, Canada

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Helsinki, Finland

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Oulu, Finland

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Bad Bramstedt, Germany

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Berlin, Germany

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Bremen, Germany

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Hamburg, Germany

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Sankt Augustin, Germany

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Vilnius, Lithuania

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Mexico City, Mexico

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Monterrey, Mexico

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San Luis Potosí City, Mexico

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Utrecht, Netherlands

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Krakow, Poland

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Lodz, Poland

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Moscow, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Related Publications (1)

• 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.

  PMID: 28507219 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

golimumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Johnson & Johnson Pharmaceutical Research & Development

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2014
• Last Updated: April 4, 2016
• Results First Posted: September 29, 2014

Record last verified: 2016-03

Locations

CA (2); US (7); FI (2); LI (1); PL (2); DE (5); AU (2); ME (3); BE (3); NL (1); BR (4); RU (3)