Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211834
• Other study ID #: CWP-TCZ301
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2010
• Last updated: November 1, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 > ULN?1.5

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
• DMARDs
Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
• Placebo
intravenously over 1 hour infusion every 4weeks
• DMARDs
Methotrexate(MTX) and/or 1 DMARDs

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with ACR20 responses	Proportion of patients with ACR20 responses at post therapy	24weeks	No
Secondary	Proportion of patients with ACR50 and ACR70 responses at post therapy		24weeks	No
Secondary	Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin		24weeks	No