Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: MRA (Tocilizumab); Other: current treatment

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987.
• With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis.
• Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL.

Exclusion criteria

• Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug.
• Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug.
• The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug.
• Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MRA (Tocilizumab); 8mg /kg /4week for 52 weeks
Other: 2; continue current treatment	Other: current treatment; continue current treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the erosion score, as determined by the modified Sharp method.	week 52
Frequency and severity of adverse events and adverse drug reactions	throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the erosion score	week 28
Changes in the joint space narrowing score and total Sharp score	week 28, 52

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 2, 2005
• First Posted (Estimate): September 5, 2005

Study Record Updates

• Last Update Posted (Estimate): February 2, 2009
• Last Update Submitted That Met QC Criteria: January 30, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: MRA012JP