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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)

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CNTO 148 (Golimumab)
Placebo
Methotrexate
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile Idiopathic Arthritis, golimumab, juvenile arthritis, GO KIDS, anti TNF alpha medications, juvenile psoriatic arthritis

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CNTO 148 (Golimumab)

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48
Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response 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.
Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48
Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48
Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.

Full Information

First Posted
October 28, 2010
Last Updated
March 31, 2016
Sponsor
Janssen Research & Development, LLC
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT01230827
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Trial has failed to meet primary - and major secondary endpoints
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Juvenile Idiopathic Arthritis, golimumab, juvenile arthritis, GO KIDS, anti TNF alpha medications, juvenile psoriatic arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CNTO 148 (Golimumab)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CNTO 148 (Golimumab)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 16 through Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48
Description
Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response 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.
Time Frame
Week 16 through Week 48
Title
Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48
Description
Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
Time Frame
Week 16 through Week 48
Title
Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48
Description
Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
Time Frame
Week 16 through Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Cincinatti
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
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
State/Province
Nova Scotia
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
28507219
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.
Results Reference
derived

Learn more about this trial

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)

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