Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144534
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 23, 2009
Information provided by:
Chugai Pharmaceutical

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 MRA213JP.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MRA (Tocilizumab) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 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 MRA213JP
Study Start Date : June 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: MRA (Tocilizumab)
8mg/kg/4 weeks

Primary Outcome Measures :
  1. Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria [ Time Frame: throughout study ]
  2. Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions [ Time Frame: throughout study ]
  3. Pharmacokinetics of the serum MRA concentration [ Time Frame: 0W,4W,8W,12W,LOBS ]

Secondary Outcome Measures :
  1. Efficacy: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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
  • In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

  • Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
  • Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
  • Have not been registered by 3 months after the full code-breaking of the preceding study
  • Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
  • Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144534

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Takahiro Kakehi Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144534     History of Changes
Other Study ID Numbers: MRA215JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

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