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Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144573
First received: September 2, 2005
Last updated: December 11, 2008
Last verified: December 2008
History of Changes

September 2, 2005
December 11, 2008
January 2005
October 2005   (final data collection date for primary outcome measure)
20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • 20% improvement based on the ACR criteria compared with the baseline value.
  • Pharmacokinetics:
  • The serum MRA concentration and pharmacokinetic parameters
  • Efficacy:
  • Safety:
  • Incidence and severity of adverse events and adverse drug reactions at 0W,4W
Complete list of historical versions of study NCT00144573 on ClinicalTrials.gov Archive Site
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, Week 4 ] [ Designated as safety issue: No ]
  • Efficacy:
  • Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable at 0W,4W
Not Provided
Not Provided
 
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment

This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: MRA(Tocilizumab)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion criteria

  • Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
  • Patients with RA at least 6 months prior to enrollment
  • Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min

Exclusion criteria

  • Patients with Class IV Steinbrocker functional impairment at enrollment
  • Patients who are undergoing dialysis
  • Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00144573
MRA221JP
Not Provided
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Director: Takahiro Kakehi Chugai Pharmaceutical
Chugai Pharmaceutical
December 2008

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