A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 28 December 2015
• Main ID: EUCTR2015-002466-22-Outside-EU/EEA
• Date of registration: 23/12/2015
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis
• Scientific title: A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open­label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis
• Target sample size: 90
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002466-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Open phase followed by double blind phase If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Canada, Costa Rica, New Zealand, United States

Contacts

• Name: Nick Yeager
• Affiliation: Amgen Inc.

• Name: Nick Yeager
• Affiliation: Amgen Inc.

Key inclusion & exclusion 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:
• 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 < 2.0 x 109/L and/or neutrophil count < 1.5 x 109/L and/or
platelet count < 150 x 109/L
• Concurrent treatment with a DMARD other than methotrexate
• Concurrent treatment of methotrexate < 10 mg/m2/week or > 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Juvenile Rheumatoid Arthritis

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Adverse events and laboratory assessment over time

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: 12+16 weeks

Main Objective: The primary objective of this study was to evaluate the safety of anakinra

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

990758

Source(s) of Monetary Support

Amgen Inc.