Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

NCT00534495 | Completed Phase 2 Results

• 3 other identifiers: N01 AR070015268200700015C-2-0-0HHSN2682007000015C
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to determine whether a rilonacept drug regimen initiated early is more effective than a similar rilonacept drug regimen initiated 4 weeks later when treating children and young adults with SJIA.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Systemic Juvenile Idiopathic Arthritis; Juvenile Rheumatoid Arthritis; Systemic Juvenile Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

  At Week 12

• Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS

  At Weeks 0- 24

Secondary Outcomes (4)

• Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70

  At Week 4 and week 12

• Pediatric Quality of Life Inventory

  At Weeks 4, 12 and 24

• Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)

  At Weeks 12 and 24

• Number of Participants With Presence of Systemic Features ( Fever, Rash)

  At Weeks 4, 12 and 24

Study Arms (2)

Group 1

EXPERIMENTAL

Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study

Biological: Rilonacept

Group 2

PLACEBO COMPARATOR

Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study

Biological: Rilonacept

Interventions

Rilonacept BIOLOGICAL

2.2 mg/kg subcutaneously

Also known as: IL-1 Trap, Arcalyst

Group 1; Group 2

Eligibility Criteria

• Age: 18 Months - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Rheumatoid Arthritis, Systemic Juvenile

Interventions

rilonacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr.Norman T.Ilowite
• Organization: Children's Hospital at Montefiore

NILOWITE@montefiore.org

718-696-2602

Study Officials

• Norman T. Ilowite, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Rheumatology, Children's Hospital at Montefiore

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: November 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

US (1)