Bucillamine Study of Holding Remission After Infliximab Dose-off

• Sponsor: Saitama Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00716248
• Collaborator: Keio University (Other)
• Enrollment: 40
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: bucillamine; Drug: methotrexate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
• Study Start Date: Jan 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: bucillamine; bucillamine 100 mg, twice a day; Drug: methotrexate; methotrexate 6 mg or more per week
Active Comparator: 2	Drug: methotrexate; methotrexate 6 mg or more per week

Outcome Measures

Primary Outcome Measures

1. The rate of disease flare [2 years]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University	Kawagoe	Saitama	Japan	350-8550

Sponsors and Collaborators

• Saitama Medical University
• Keio University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00716248
• Other Study ID Numbers: SMC-94
• First Posted: Jul 16, 2008
• Last Update Posted: Jan 5, 2011
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Bucillamine; Methotrexate

Study Results

No Results Posted as of Jan 5, 2011