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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01211834
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: tocilizumab; Drug: DMARDs; Drug: Placebo; Drug: DMARDs	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tocilizumab 8mg/kg+DMARDs	Drug: tocilizumab; intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks; Drug: DMARDs; Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
Placebo Comparator: Placebo+DMARDs	Drug: Placebo; intravenously over 1 hour infusion every 4weeks; Drug: DMARDs; Methotrexate(MTX) and/or 1 DMARDs

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with ACR20 responses [24weeks]

   Proportion of patients with ACR20 responses at post therapy

Secondary Outcome Measures

1. Proportion of patients with ACR50 and ACR70 responses at post therapy [24weeks]

2. Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin [24weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 > ULNⅹ1.5

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01211834
• Other Study ID Numbers: CWP-TCZ301
• First Posted: Sep 30, 2010
• Last Update Posted: Nov 3, 2010
• Last Verified: Nov 1, 2010

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents

Study Results

No Results Posted as of Nov 3, 2010