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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00534495 |
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Date of registration:
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24/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults
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Scientific title:
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Randomized Placebo Phase Study of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT) |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00534495 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Norman T. Ilowite, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montefiore Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Fulfills International League Against Rheumatism (ILAR) criteria for SJIA
- Duration of SJIA lasting at least 6 weeks since onset
- Active disease as defined by at least two joints with active disease
- Not currently receiving methotrexate OR if taking methotrexate, the dose has remained
stable or has been discontinued for 4 weeks prior to screening
- Has never received certain biologics OR if previously received biologics, discontinued
etanercept for at least 4 weeks prior to screening and discontinued infliximab or
adalimumab for at least 8 weeks prior to screening
- Not currently receiving corticosteroids OR if taking oral corticosteroids, the dose
has remained stable between 2 and 60 mg/day for at least 2 weeks prior to screening
Exclusion Criteria:
- Past treatment with anakinra, rilonacept, or other biologic IL-1 inhibitor
- Treatment with other disease-modifying antirheumatic drugs (DMARDs) including, but not
limited to, azathioprine, sulfasalazine, cyclosporine, and thalidomide within 4 weeks
of screening
- Treatment with leflunomide without cholestyramine washout at the end of therapy
- Treatment with cyclophosphamide within 3 months of study entry
- Treatment with tacrolimus or tocilizumab within 4 weeks of study entry
- Treatment with rituximab within 6 months of study entry
- Treatment with intravenous immunoglobulin (IVIG) within 4 weeks of screening
- Kidney disease
- AST or ALT levels more than two times the upper limit of normal
- Bilirubin levels higher than 1.5 mg/dl
- Thrombocytopenia, leukopenia, or neutropenia
- Abnormal prothrombin time (PT) and partial thromboplastin time (PTT) tests
- Low levels of plasma fibrinogen
- Evidence of chronic recurrent infection or other significant, non-SJIA illness that
might interfere with study participation
- Psychological or cognitive difficulties that might interfere with study participation
- Current drug or alcohol abuse
- Anticipated poor compliance to assigned study regimen
- Participation in another clinical trial within 30 days of study entry
- Major surgical procedure within 3 months of study entry
Age minimum:
18 Months
Age maximum:
19 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Juvenile Idiopathic Arthritis
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Intervention(s)
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Biological: Rilonacept
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Primary Outcome(s)
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Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS
[Time Frame: At Weeks 0- 24]
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Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids
[Time Frame: At Week 12]
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Secondary Outcome(s)
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Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)
[Time Frame: At Weeks 12 and 24]
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Number of Participants With Presence of Systemic Features ( Fever, Rash)
[Time Frame: At Weeks 4, 12 and 24]
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Pediatric Quality of Life Inventory
[Time Frame: At Weeks 4, 12 and 24]
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Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70
[Time Frame: At Week 4 and week 12]
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Secondary ID(s)
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HHSN2682007000015C
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N01 AR070015
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268200700015C-2-0-0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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