Bucillamine Study of Holding Remission After Infliximab Dose-off

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Saitama Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Keio University
Information provided by:
Saitama Medical University
ClinicalTrials.gov Identifier:
NCT00716248
First received: July 8, 2008
Last updated: January 4, 2011
Last verified: September 2009
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: bucillamine
Drug: methotrexate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate

Resource links provided by NLM:


Further study details as provided by Saitama Medical University:

Primary Outcome Measures:
  • The rate of disease flare [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716248

Locations
Japan
Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama, Japan, 350-8550
Sponsors and Collaborators
Saitama Medical University
Keio University
  More Information

No publications provided

Responsible Party: Hideto Kameda, Department of Internal Medicine, School of Medicine, Keio University
ClinicalTrials.gov Identifier: NCT00716248     History of Changes
Other Study ID Numbers: SMC-94
Study First Received: July 8, 2008
Last Updated: January 4, 2011
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bucillamine
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 22, 2014