Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

NCT00144599 | Completed Phase 3

• 1 other identifier: MRA316JP
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Conditions

Systemic Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (4)

• Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS

  open-label period

• Efficacy:Percentage of patients in whom effects were maintained

  Blind period

• Safety:Incidence and severity of adverse events and adverse drug reactions

  whole period

• Pharmacokinetics:The time course of the trough serum MRA concentration

  whole period

Secondary Outcomes (2)

• Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score

  Open-label period

• Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS

  Blind Period

Study Arms (2)

1

EXPERIMENTAL

Drug: MRA(Tocilizumab)

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

MRA(Tocilizumab) DRUG

1

placebo DRUG

2

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
• Patients between 2 and 19 years of age
• Patients who are under 16 years of age at onset
• Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions

You may not qualify if:

• Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product
• Patients who have received the following treatments within 4 weeks before treatment with the investigational product
• Surgical treatment (e.g., operation)
• Plasma exchange therapy"

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Related Publications (3)

• Aoki C, Inaba Y, Choe H, Kaneko U, Hara R, Miyamae T, Imagawa T, Mori M, Oba MS, Yokota S, Saito T. Discrepancy between clinical and radiological responses to tocilizumab treatment in patients with systemic-onset juvenile idiopathic arthritis. J Rheumatol. 2014 Jun;41(6):1171-7. doi: 10.3899/jrheum.130924. Epub 2014 May 1.

  PMID: 24786929 DERIVED

• Yokota S, Imagawa T, Mori M, Miyamae T, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Longterm safety and effectiveness of the anti-interleukin 6 receptor monoclonal antibody tocilizumab in patients with systemic juvenile idiopathic arthritis in Japan. J Rheumatol. 2014 Apr;41(4):759-67. doi: 10.3899/jrheum.130690. Epub 2014 Mar 15.

  PMID: 24634205 DERIVED

• Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006. doi: 10.1016/S0140-6736(08)60454-7.

  PMID: 18358927 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Takahiro Kakehi

  Chugai Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: May 1, 2004
• Study Completion: October 1, 2005
• Last Updated: July 30, 2008

Record last verified: 2008-07