PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: MRA(Tocilizumab)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chugoku, Japan
    • Chugoku region
  • Chukyo, Japan
    • Chukyo region
  • Hokkaido, Japan
    • Hokkaido region
  • Hokuriku, Japan
    • Hokuriku region
  • Kansai, Japan
    • Kansai Region
  • Kanto, Japan
    • Kanto region
  • Kousinetsu, Japan
    • Kousinetsu region
  • Kyushu, Japan
    • Kyushu region
  • Sikoku, Japan
    • Sikoku region
  • Tohoku, Japan
    • Tohoku region

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
• Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
• Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

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 Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug

• Subjected to any of the following within 4 weeks before administration of the study drug:

  1. Surgical treatment (operations,etc.).
  2. Plasma exchange method

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MRA(Tocilizumab); 8mg/kg/4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of ACR 20％ improvement at the final visit	throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.	throughout study
Time course of DAS28 to the final visit.	throughout study
Time course of steroid sparing effect from first visit to final visit.	throughout study

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Investigators: Study Director: Yuji Kimura, Chugai Pharmaceutical Co., Ltd. Research Dept.1

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 25, 2006
• First Submitted That Met QC Criteria: September 25, 2006
• First Posted (Estimate): September 26, 2006

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 22, 2009
• Last Verified: December 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: MRA225JP