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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical

Criteria

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