PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)
An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
1 other identifier
interventional
20
1 country
10
Brief Summary
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started May 2006
Typical duration for phase_3 rheumatoid-arthritis
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 25, 2006
CompletedFirst Posted
Study publicly available on registry
September 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedDecember 23, 2009
December 1, 2009
2.3 years
September 25, 2006
December 22, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of ACR 20％ improvement at the final visit
throughout study
Secondary Outcomes (3)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- Surgical treatment (operations,etc.).
- Plasma exchange method
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
Tōhoku, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yuji Kimura
Chugai Pharmaceutical Co., Ltd. Research Dept.1
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 25, 2006
First Posted
September 26, 2006
Study Start
May 1, 2006
Primary Completion
August 1, 2008
Study Completion
February 1, 2009
Last Updated
December 23, 2009
Record last verified: 2009-12