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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 therapy

Change 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

Page last updated: August 23, 2015

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