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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014