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Study of MRA in Patients With Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144651
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: MRA(Tocilizumab)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • ACR 20% responder rate compared to the pre-treatment in the preceding study [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events and adverse drug reactions [ Time Frame: week0,week4,week8,week12,and LOBS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time course of DAS28,compared to the pre-treatment in the preceding study [ Time Frame: week 0,week 4,week 8,week 12, LOBS ] [ Designated as safety issue: No ]
  • Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study [ Time Frame: week 0,week 4,week 8,week 12, LOBS ] [ Designated as safety issue: No ]
  • ACR N AUC compared to the pre-treatment in the preceding study [ Time Frame: week 0,week 4,week 8,week 12, LOBS ] [ Designated as safety issue: No ]
  • Time course of the ACR core set variables compared to the pre-treatment in the preceding study [ Time Frame: week 0,week 4,week 8,week 12, LOBS ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: August 2001
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)
8mg/kg/4 weeks for 1 year

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144651

Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Takahiro Kakehi Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144651     History of Changes
Other Study ID Numbers: MRA010JP
Study First Received: September 2, 2005
Last Updated: December 21, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013