Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study

UMIN ID: UMIN000000837

Registered date:01/10/2007

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 2007/10/01
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Bucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment)
Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment)
Combination therapy of bucillamine and salazosulphapyridine (over the study period)

Outcome(s)

• Primary Outcome: Proportion of patients with "good response" according to EULAR three-category scale at months 6 and 12.
• Secondary Outcome: 1)Proportion of patients with "moderate response" according to EULAR three-category scale at months 6 and 12. 2)Proportion of patients with "remission",defined as a DAS 28 of < 2.6 at months 6 and 12.. 3)Change from baseline in the Sharp/ van der Heijde score at the end of study 4)Improvement of physical function (as measured by the change from baseline in the modified HAQ).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: [Complication] Patients who had any of the following diagnoses or medical history: 1)Autoimmune diseases such as systemic lupus erythematosus and malignancy. 2)Drug allergy 3)Severe heart, lung, liver, kidney and haematological disorders [Treatment] 4)Patient who had received treatment with bucillamine or salazosulphapirydine 5)Patient who received intraarticular, intramuscular, or epidural injection of corticosteroids within 4 weeks prior to the entry or during the study. Patients who received systemic coritosteroids with a dose of >10mg of prednisolone or patients whose cortico-steroid dose were changed within 4 weeks prior to the study entry or during the study. (except for patients who developed side effect related to corticosteroids) 6)Patient who received NSIADs with an overdosage or patients who had alterations in dose or usage of NSAIDs within 4 weeks prior to the study entry or during the study. [Surgery] 7)Patients who had surgery for rheumatoid arthritis within 6 months prior to the study entry and during the study) 8)Patient who had the following treatment or procedure: plasma exchange, leukocyte -depleted therapy or arthrocentesis against affected joints within 4 weeks prior to the study entry or during the study. [Others] 9)Patients who is in pregnancy, lactating, or with a possibility of the pregnancy and women who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study. 10)Patient who can not go to a hospital for check-up on a an appointed day. 11)Patient who participated other clinical trial program within 4 months prior to the study entry (including post-marketing clinical study) 12)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of the study.

Related Information

• Primary Sponsor: BASIC study group
• Secondary Sponsor: None
• Source(s) of Monetary Support: None,None