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)

This study has been terminated.
(Trial has failed to meet primary - and major secondary endpoints)
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01230827
First received: October 28, 2010
Last updated: September 23, 2014
Last verified: September 2014

October 28, 2010
September 23, 2014
December 2010
September 2013   (final data collection date for primary outcome measure)
Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Experienced a Flare of Disease [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
Percentage of participants with ACR 30 response who experienced a flare of disease will be calculated as number of participants with response divided by number of participants randomized. Flare of disease is defined as 30 percent (%) or more improvement in at least 3 and 30% or more worsening in no more than 1 of the 6 of the ACR pediatric (Ped) core set variables. 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.
Comparison of disease flare. Flare as defined by 30% or more than 3 of the 6 ACR (American College of Rheumatology) Ped (pediatric) Core Set Variables beginning at Week 16 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01230827 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    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 is defined as 30 percent or more improvement from baseline in at least 3 of the following 6 components: physicians global assessment of disease, participant/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 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    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 (less than 20 mm/hour) or C-reactive protein (less than 20 mm/hour); 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 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    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 (less than 20 mm/hour) or C-reactive protein (less than 20 mm/hour); physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
  • Improvement in physical function by physician and patient assessment [ Time Frame: every 4 weeks from Week 0 to Week 48, then every 12 weeks to Week 152 ] [ Designated as safety issue: No ]
  • Study of drug metabolism [ Time Frame: From week 0 to week 152 ] [ Designated as safety issue: No ]
  • Safety of golimumab by measuring adverse events and laboratory values [ Time Frame: every 4 weeks from Week 0 to Week 48, then every 12 weeks to Week 152 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Juvenile Idiopathic Arthritis
  • Drug: CNTO 148 (Golimumab)
    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.
  • Drug: Placebo
    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.
  • Drug: Methotrexate
    All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.
  • Experimental: CNTO 148 (Golimumab)
    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.
    Interventions:
    • Drug: CNTO 148 (Golimumab)
    • Drug: Methotrexate
  • Placebo Comparator: Placebo
    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.
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
173
May 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States,   Austria,   Russian Federation,   Brazil,   Canada,   Finland,   Germany,   Lithuania,   Mexico,   Netherlands,   Poland
 
NCT01230827
CR017089, CNTO148JIA3001, 2009-015019-42
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Schering-Plough
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP