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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380601
• Other study ID #: MRA225JP
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2006
• Last updated: December 22, 2009
• Start date: May 2006
• Est. completion date: February 2009

Study information

• Verified date: December 2009
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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-? 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MRA(Tocilizumab)
8mg/kg/4 weeks

Locations

Country	Name	City	State
Japan	Chugoku region	Chugoku
Japan	Chukyo region	Chukyo
Japan	Hokkaido region	Hokkaido
Japan	Hokuriku region	Hokuriku
Japan	Kansai region	Kansai
Japan	Kanto region	Kanto
Japan	Kousinetsu region	Kousinetsu
Japan	Kyushu region	Kyushu
Japan	Sikoku region	Sikoku
Japan	Tohoku region	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of ACR 20% improvement at the final visit		throughout study	No
Secondary	Time course of the frequency of ACR 20%, 50% and 70% improvement,time course of individual items within the ACR core set.		throughout study	No
Secondary	Time course of DAS28 to the final visit.		throughout study	No
Secondary	Time course of steroid sparing effect from first visit to final visit.		throughout study	No