Study of MRA in Patients With Rheumatoid Arthritis (RA)

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00144651
• Collaborator: (none)
• Enrollment: 135
• Arm: 1
• Duration (Months): 94

Study Details

Study Description

Brief Summary

This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: MRA(Tocilizumab); 8mg/kg/4 weeks for 1 year

Outcome Measures

Primary Outcome Measures

1. ACR 20% responder rate compared to the pre-treatment in the preceding study [throughout study]

2. Frequency and severity of adverse events and adverse drug reactions [week0,week4,week8,week12,and LOBS]

Secondary Outcome Measures

1. Time course of DAS28,compared to the pre-treatment in the preceding study [week 0,week 4,week 8,week 12, LOBS]

2. Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study [week 0,week 4,week 8,week 12, LOBS]

3. ACR N AUC compared to the pre-treatment in the preceding study [week 0,week 4,week 8,week 12, LOBS]

4. Time course of the ACR core set variables compared to the pre-treatment in the preceding study [week 0,week 4,week 8,week 12, LOBS]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.

• Patients confirmed to have shown the safety in the preceding study.

Exclusion Criteria:

• Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug

• Patients who received any of the following treatments between the start of preceding study and the registration of this study.

1. Plasma exchange therapy

2. Surgical treatment (e.g., operation)

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: NCT00144651
• Other Study ID Numbers: MRA010JP
• 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