Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

NCT00144612 | Completed Phase 3

• 1 other identifier: MRA317JP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Conditions

Systemic Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

• Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)

  whole period

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

  whole period

• Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks

  0 week and every 2 weeks

Secondary Outcomes (1)

• Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks

  0 week and every 2 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab) DRUG

8mg/kg/2weeks

1

Eligibility Criteria

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

You may qualify if:

• Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
• the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
• Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
• Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

You may not qualify if:

• Patients who were not enrolled by 3 months after completion of the previous study
• Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: July 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12