Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00144547
• Collaborator: (none)
• Enrollment: 241
• Arm: 1
• Duration (Months): 62

Study Details

Study Description

Brief Summary

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA012JP.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: MRA(Tocilizumab); 8mg/kg(i.v.)/4weeks

Outcome Measures

Primary Outcome Measures

1. Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP) [0W,4W,8W,12W,LOBS]

2. Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria [0W,4W,8W,12W,LOBS]

Secondary Outcome Measures

1. Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set [0W,4W,8W,12W,LOBS]

2. Frequency, severity, and seriousness of adverse events and adverse drug reactions [Throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• Patients must suffer from RA, and must have participated in the preceding study.

• Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

• Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug

• Patients who have not been registered by 3 months after week 52 of the preceding study

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.

• Responsible Party: Chugai Pharmaceutical
• ClinicalTrials.gov Identifier: NCT00144547
• Other Study ID Numbers: MRA214JP
• First Posted: Sep 5, 2005
• Last Update Posted: Aug 9, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Aug 9, 2013