INTERVENTION: Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Current Sponsor code: CNTO148 Other descriptive name: Human anti‐TNF‐alpha monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Juvenile Idiopathic Arthritis (JIA) ; MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by = 5 joints with active arthritis despite methotrexate (MTX) therapy for = 3 months. Primary end point(s): The primary endpoint is the proportion of subjects who are ACR Ped 30 responders at Week 16 and do not experience a flare of disease between Week 16 and Week 48. Secondary Objective: The secondary objectives of this study are to evaluate golimumab in pediatric subjects with JIA with respect to:; ; 1. Safety.; 2. Physical function.; 3. Quality of life.; 4. Disease activity status over time.; 5. Pharmacokinetics and immunogenicity.; 6. Pharmacodynamics. Timepoint(s) of evaluation of this end point: At week 48 SECONDARY OUTCOME: Secondary end point(s): 1. The proportion of ACR Ped 30 responders at Week 16 with ACR Ped 30 response at Week 48. ; 2. The proportion of subjects who are responders at Week 16 and have inactive disease at Week 48. ; 3. The proportion of subjects, who are responders at Week 16 and are in clinical remission while on medication for JIA at Week 48. Timepoint(s) of evaluation of this end point: At week 48 INCLUSION CRITERIA: 1. Pediatric subject ages 2 to less than 18 years of age. Age must not be a factor in the ability to continue follow‐up with the investigator through the end of the study. 2. Diagnosis must be made per JIA ILAR diagnostic criteria and the onset of disease must have been before the subject’s 16th birthday Active JIA of one of the subtypes described in the protocol. 3. Disease duration of at least 6 months before study entry. 4. Must have = 5 joints with active arthritis as defined by ACR criteria. 5. Active JIA despite current use of oral, intramuscular or subcutaneous methotrexate. 6. If using corticosteroids; must be on a stable dose of = 10 mg prednisone equivalent or 0.2 mg/kg/day (whichever is less) for = 4 weeks before first administration of study agent. If currently not using corticosteroids, the subject must have not received corticosteroids for at least 4 weeks before the first dose administration. 7. If using NSAIDs, must be on
<b>OBJECTIVE: </b>This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA).<b>METHODS: </b>In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety.<b>RESULTS: </b>Among 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1% of all injections. PK analysis confirmed adequate golimumab dosing for polyJIA.<b>CONCLUSION: </b>Although the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred.<b>Clinical Trial Registration: </b>NCT01230827; Results.
Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 Pharmaceutical Form: Solution for injection INN or Proposed
INN:
Golimumab Current Sponsor code: CNTO148 Other descriptive name: Human anti‐TNF‐alpha monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
CONDITION:
Juvenile Idiopathic Arthritis (JIA) ; MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20]
PRIMARY OUTCOME:
Main Objective: The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by = 5 joints with active arthritis despite methotrexate (MTX) therapy for = 3 months. Primary end point(s): The primary endpoint is the proportion of subjects who are ACR Ped 30 responders at Week 16 and do not experience a flare of disease between Week 16 and Week 48. Secondary Objective: The secondary objectives of this study are to evaluate golimumab in pediatric subjects with JIA with respect to:; ; 1. Safety.; 2. Physical function.; 3. Quality of life.; 4. Disease activity status over time.; 5. Pharmacokinetics and immunogenicity.; 6. Pharmacodynamics. Timepoint(s) of evaluation of this end point: At week 48
SECONDARY OUTCOME:
Secondary end point(s): 1. The proportion of ACR Ped 30 responders at Week 16 with ACR Ped 30 response at Week 48. ; 2. The proportion of subjects who are responders at Week 16 and have inactive disease at Week 48. ; 3. The proportion of subjects, who are responders at Week 16 and are in clinical remission while on medication for JIA at Week 48. Timepoint(s) of evaluation of this end point: At week 48
INCLUSION CRITERIA:
1. Pediatric subject ages 2 to less than 18 years of age. Age must not be a factor in the ability to continue follow‐up with the investigator through the end of the study. 2. Diagnosis must be made per JIA ILAR diagnostic criteria and the onset of disease must have been before the subject’s 16th birthday Active JIA of one of the subtypes described in the protocol. 3. Disease duration of at least 6 months before study entry. 4. Must have = 5 joints with active arthritis as defined by ACR criteria. 5. Active JIA despite current use of oral, intramuscular or subcutaneous methotrexate. 6. If using corticosteroids; must be on a stable dose of = 10 mg prednisone equivalent or 0.2 mg/kg/day (whichever is less) for = 4 weeks before first administration of study agent. If currently not using corticosteroids, the subject must have not received corticosteroids for at least 4 weeks before the first dose administration. 7. If using NSAIDs, must be on
