Bucillamine Study of Holding Remission After Infliximab Dose-off
This trial is active, not recruiting.
|Sponsor||Saitama Medical University|
|Start date||January 2007|
|End date||December 2011|
|Trial size||40 participants|
|Trial identifier||NCT00716248, SMC-94|
Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
The rate of disease flare
time frame: 2 years
Male or female participants at least 20 years old.
Inclusion Criteria: - RA according to American College of Radiology (ACR) classification criteria - Age of 20 or greater - DAS28-ESR < 3.2 or DAS28-CRP < 2.6 for more than 6 months Exclusion Criteria: - Previously teated with bucillamine - Pregnancy or lactation
|Official title||The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate|
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