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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144547
First received: September 2, 2005
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: MRA(Tocilizumab)
Phase 3

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 III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • 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) [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]
  • Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]
  • Frequency, severity, and seriousness of adverse events and adverse drug reactions [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 241
Study Start Date: April 2004
Study Completion Date: June 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)
8mg/kg(i.v.)/4weeks

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144547

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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144547     History of Changes
Other Study ID Numbers: MRA214JP
Study First Received: September 2, 2005
Last Updated: August 6, 2013
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 April 17, 2014