Juvenile Rheumatoid Arthritis
Conditions
Interventions
Product Name: anakinra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Boys or girls age 2 to 17 years (inclusive) • Minimum weight of 10 kg • Availability of an adult to assist with administration of SC injections of study drug and/or subjects capable of adequately performing self-injection technique as judged by the investigator • Available for assessments • Polyarticular, pauciarticular or systemic disease onset • Active polyarticular-course JRA with at least 5 swollen joints due to active arthritis (not bony overgrowth) and 3 joints with limitation of motion (LOM) at screening and the day 1 visit • Stable doses of background methotrexate (minimum 10 mg/m2/week, maximum 40 mg/week) for 6 consecutive weeks before the first dose of anakinra and throughout the trial (subjects not receiving background methotrexate or any other DMARD for 6 weeks before the first dose of anakinra could be enrolled but not initiate methotrexate treatment while participating in this study) • Subjects who continued methotrexate were required to take either 1 to 5 mgs/day folic acid at least 5 days/week or 2.5 to 15 mgs folinic acid the day after methotrexate administration • Subjects had at least a 4-week washout of any other biologic therapy (eg, etanercept and infliximab) before the first dose of anakinra • Stable doses of NSAIDS (including Cox-2 inhibitors e.g. celecoxib and rofecoxib) and systemic oral corticosteroids (= 10 mg/day or 0.2 mg/kg/day of prednisone; whichever was less) for 4 weeks before the first dose of anakinra and during the trial • Subjects who received leflunomide must have completed the prescribed course of cholestyramine washout • Provision of written informed consent for participation in the study by the subject or legally acceptable representative before any study-specific procedure was performed Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Presence of any uncontrolled, clinically significant systemic disease, hepatic, renal, neurological, endocrine, cardiac, gastrointestinal (except NSAID-induced GI problems), or hematologic disease within 24 weeks of first dose of anakinra • Presence of symptoms of systemic disease at screening (intermittent fever, rash, hepatosplenomegaly, pericarditis) • Known diagnosis of hepatitis or HIV • A malignancy other than basal cell or in situ carcinoma of the cervix within the previous 5 years • Presence of any other rheumatic disease or major chronic infectious, inflammatory, immunologic disease (inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus) • Infection at screening or development of frequent, acute or chronic infection within 4 weeks • Joint replacement required during the study • ALT or AST > 2.0 or creatinine > 1.5 times the upper limit of normal range (confirmed by repeated measure) • White blood cell count 40 mg/week • Received intra-articular or systemic corticosteroid injection within 4 weeks • Received live viral vaccines within 3 months of study • Current enrollment in any other interventional clinical study or concurrent treatment with an investigational agent within 4 weeks of study • Active substance abuse • Known allergy to E coli-derived products • Any disorder that compromised the ability to give informed consent for participation in the study, comply with protocol procedures, and/or be available for follow-up assessment • Lack of adequate contraceptive precautions • Pregnancy (eg, positive test for human chorionic gonadotropin), ongoing breastfeeding, or intention to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to evaluate the safety of anakinra ;Secondary Objective: Not applicable;Primary end point(s): Adverse events and laboratory assessment over time;Timepoint(s) of evaluation of this end point: 12+16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Australia, Canada, Costa Rica, New Zealand, United States
Contacts
Public ContactNick Yeager
Amgen Inc.
Outcome results
None listed