PhaseⅢOpen-Label Study of MRA for Rheumatoid Arthritis(RA) - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00380601

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Frequency of ACR 20％ improvement at the final visit [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time course of the frequency of ACR 20％,　50％ and 70％ improvement,time course of individual items within the ACR core set. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Time course of DAS28 to the final visit. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Time course of steroid sparing effect from first visit to final visit. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	May 2006
Estimated Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MRA(Tocilizumab) 8mg/kg/4 weeks

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380601

Locations

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Yuji Kimura

Chugai Pharmaceutical Co., Ltd. Research Dept.1

More Information

Responsible Party:	Chugai Pharmaceutical Co.,Ltd. ( Chugai Pharmaceutical Co.,Ltd. )
Study ID Numbers:	MRA225JP
Study First Received:	September 25, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00380601
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009