Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Information source: JW Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: tocilizumab (Drug); DMARDs (Drug); Placebo (Drug); DMARDs (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: JW Pharmaceutical
Summary
The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in
combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in
patients with moderate to severe active RA and inadequate response to current DMARD
treatment
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proportion of patients with ACR20 responses
Secondary outcome: Proportion of patients with ACR50 and ACR70 responses at post therapyChange of DAS28, HAQ, individual parameter in ACR core set, hemoglobin
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult patients, >= 18 years of age
- Active RA of > 6monts duration
- Received permitted DMARDs each at a stable dose for at least 8 weeks
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Significant systemic involvement secondary to RA
- ALT or AST > ULNā
¹1. 5
- Platelet count < 100,000/mm3
- Hemoglobin < 8. 5 g/dL
- White blood cells < 3,000/mm3
- Absolute neutrophil count < 2,000/mm3
- Absolute lymphocyte count < 500/mm3
Locations and Contacts
Seoul National Univ. Hospital, Seoul 110-744, Korea, Republic of
Additional Information
Starting date: October 2009
Last updated: November 1, 2010
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