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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144534
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009

September 2, 2005
December 21, 2009
June 2004
August 2005   (final data collection date for primary outcome measure)
  • Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetics of the serum MRA concentration [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]
  • The frequency of amelioration of at least 20% in terms of the ACR criteria
  • Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
  • The serum MRA concentration
  • Efficacy:
  • Safety:
  • Pharmacokinetics:
  • at 0W,4W,8W,12W,LOBS
Complete list of historical versions of study NCT00144534 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  • 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
  • at 0W,4W,8W,12W,LOBS
Not Provided
Not Provided
 
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: MRA (Tocilizumab)
8mg/kg/4 weeks
Experimental: 1
Intervention: Drug: MRA (Tocilizumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
June 2009
August 2005   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00144534
MRA215JP
Not Provided
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Director: Takahiro Kakehi Chugai Pharmaceutical
Chugai Pharmaceutical
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP