RA(Rheumatoid Arthritis)
Conditions
Interventions
Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months
Sponsors
St Luke's International Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfilled the ACR and EULAR classification criteria for RA within 6 months . (Onset less than 1 year )
Exclusion criteria
Exclusion criteria: The past and complications 1)Patients with rheumatic diseases other than Sjogren's syndrome 2)Patient who has allergy in sulfa drugs 3)Patient with complications, such as the clinically signficant heart, lungs,liver and kidney disease,and blood dyscrasia Medicine 4)Patient with the history(less than 3 months)of SSZ, BUC, and MTX use 5)Patient with the history of biological DMARDs use 6)Patient who received intra-articular steroid injection within 4 weeks before the enrollment 7)Patient treated with steroid medication(oral,intravenous,intramuscular, or rectal administration;PSL equivalent dose>5mg/day within four weeks, before the enrollment) Operation/Treatment 8)Patient had an operation for RA within 6 months, before the enrollment 9)Patients with one of the following treatment 1 Plasma exchange 2 Leukocyte depletion therapy 3 Joint puncture and drainage for evaluated joints Others 10)Age < 20 years old or > 80 years old 11)Prengnant or lactating patients, and patients who wish to become pregnant within three months after the enrollment. Patients who wish their partner's pregnancy by three months after the test period end which is a schedule during the test period 12)Patients whom the investigator considers to be unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28- tender joint count (T28), 28- swollen joint count (S28), CRP,MMP-3,Rheumatoid ractor,Anti-CCP, antibody,ESR GH,VAS(mm), mHAQ | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28(ESR/CRP), Remmision achievement rate on DAS28, EULAR response rate, CDAI:Clinical Disease Activity Index, ACR 50 and 70 response rates, Hand and foot X-ray (using modified Total Sharp Score method), Bone density(Lumber spine or femoral neck) | — |
Countries
Japan
Contacts
Public ContactMitsumasa Kishimoto
St Luke's International Hospital The Section of Allergy&Rheumatology
Outcome results
None listed