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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: MRA(Tocilizumab)

• Registration Number: NCT00380601
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-26
• Primary Completion: 2008-08
• Study Completion: 2009-02
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-22
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MRA(Tocilizumab)	-

Primary Outcome Measures

Name	Time	Method
Frequency of ACR 20％ improvement at the final visit	throughout study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Hokuriku region; 🇯🇵 Hokuriku, Japan

Kansai region; 🇯🇵 Kansai, Japan

Kousinetsu region; 🇯🇵 Kousinetsu, Japan

Kyushu region; 🇯🇵 Kyushu, Japan

Chugoku region; 🇯🇵 Chugoku, Japan

Chukyo region; 🇯🇵 Chukyo, Japan

Hokkaido region; 🇯🇵 Hokkaido, Japan

Kanto region; 🇯🇵 Kanto, Japan

Tohoku region; 🇯🇵 Tohoku, Japan

Sikoku region; 🇯🇵 Sikoku, Japan