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

This study has been completed.
Information provided by:
Chugai Pharmaceutical Identifier:
First received: September 2, 2005
Last updated: December 11, 2008
Last verified: December 2008
This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.

Condition Intervention
Rheumatoid Arthritis Drug: MRA(Tocilizumab)

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, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment

Resource links provided by NLM:

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • 20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: January 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00144573

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

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144573     History of Changes
Other Study ID Numbers: MRA221JP
Study First Received: September 2, 2005
Last Updated: December 11, 2008

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Renal Insufficiency
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017