This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Chugai Pharmaceutical Identifier:
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009
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 Intervention Phase
Rheumatoid Arthritis Drug: MRA (Tocilizumab) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Chugai Pharmaceutical:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 115
Study Start Date: June 2004
Study Completion Date: June 2009
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA (Tocilizumab)
8mg/kg/4 weeks


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
  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 identifier: NCT00144534

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

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144534     History of Changes
Other Study ID Numbers: MRA215JP
Study First Received: September 2, 2005
Last Updated: December 21, 2009

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 17, 2017