Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00144664
• Collaborator: (none)
• Enrollment: 19
• Arm: 1
• Duration (Months): 11

Study Details

Study Description

Brief Summary

This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

Condition or Disease	Intervention/Treatment	Phase
Systemic Juvenile Idiopathic Arthritis	Drug: MRA(Tocilizumab)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 MRA(Tocilizumab)	Drug: MRA(Tocilizumab)

Outcome Measures

Primary Outcome Measures

1. Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS [whole period]

2. Safety:Incidence and severity of adverse events and adverse drug reactions [whole period]

3. Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration [whole period]

Secondary Outcome Measures

1. Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS [whole period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)

• Patients aged at least 2 years old and less than 20.

• Patients aged less than 16 years old at time of onset

Exclusion criteria

• Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product

• Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chugai Pharmaceutical

Investigators

• Study Director: Takahiro Kakehi, Chugai Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00144664
• Other Study ID Numbers: MRA318JP
• First Posted: Sep 5, 2005
• Last Update Posted: Jul 30, 2008
• Last Verified: Jul 1, 2008

• Additional relevant MeSH terms: Arthritis; Arthritis, Juvenile

Study Results

No Results Posted as of Jul 30, 2008