Rheumatoid arthritis
Conditions
Interventions
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)
Sponsors
BASIC study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients, fulfilled the ACR 1987 revised criteria for the classification of rheumatoid arthritis. (20-75 years old) 2)Outpatients (there are no schedules of hospitalization during a clinical trial period.) 3)Patients with active disease of <5 years'duration. Active disease as defined by the presence of >=3 tender and >= 3 swollen joints and with either CRP >=2.0mg/dl or ESR 30mm/hr. 4)Patients who can provide written informed consent by themselves.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with "good response" according to EULAR three-category scale at months 6 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactYasuo Suzuki
Tokai University medical school affiliated hospital Department of Rheumatology
Outcome results
None listed