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

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00380601
• Collaborator: (none)
• Enrollment: 20
• Locations: 10
• Arm: 1
• Duration (Months): 33.1
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Frequency of ACR 20％ improvement at the final visit [throughout study]

Secondary Outcome Measures

1. Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set. [throughout study]

2. Time course of DAS28 to the final visit. [throughout study]

3. Time course of steroid sparing effect from first visit to final visit. [throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chugoku region	Chugoku		Japan
2	Chukyo region	Chukyo		Japan
3	Hokkaido region	Hokkaido		Japan
4	Hokuriku region	Hokuriku		Japan
5	Kansai region	Kansai		Japan
6	Kanto region	Kanto		Japan
7	Kousinetsu region	Kousinetsu		Japan
8	Kyushu region	Kyushu		Japan
9	Sikoku region	Sikoku		Japan
10	Tohoku region	Tohoku		Japan

Sponsors and Collaborators

• Chugai Pharmaceutical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00380601
• Other Study ID Numbers: MRA225JP
• First Posted: Sep 26, 2006
• Last Update Posted: Dec 23, 2009
• Last Verified: Dec 1, 2009

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Dec 23, 2009