A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-UMIN000006702
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 290
Not provided
A patient who has any of the following will be excluded from the study. 1.When a patient refuses to give or withdraws his or her consent. 2.A patient who with concurrent other inflammatory joint diseases (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, SLE, systemic sclerosis and mixed connective tissue disease), or history of these diseases. Sjogren syndrome is not included in these diseases. 3.When a patient has contraindications for MTX or tacrolimus. 4.When a patient has an active infectious disease. 5.A patient who is positive for HBs antigen or HBV DNA is excluded unless he/she receive nucleotide analogue and becomes negative for HBV DNA. 6.When a patient has severe hepatic disease, which is contraindication for MTX. 7.When a patient has severe renal disease, which is contraindication for MTX 8.When a patient has concurrent malignancy, lymphoma, leukemia or lymphproliferative disorder except for skin cancer (basal cell carcinoma or epithelial cell carcinoma) and cervical cancer of uterus which were completely resected and has not recurred for more than 5 years, 9.When a patient has uncontrollable comorbidities (i.e., severe diabetes, unstable ischemic heart disease, stroke within the last 1 year). 10.A patient with latent tuberculosis unless he/she receives proper chemoprophylaxis according to the Japan College of Rheumatology guideline. 11.When a patient received investigational drug within the last month or within the five times of half-life, whichever is longer. 12.When a patient's body weight less than 40kg. 13.When a patient is under breastfeeding or pregnant, or has plan to be pregnant in 24 weeks. 14.When a doctor judges a patient cannot to visit outpatient clinic regularly for 24 weeks. 15.When a doctor judges a patient not appropriate to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission rates at week 24 by SDAI or Boolean index
- Secondary Outcome Measures
Name Time Method 1.Remission rates at week 48 and 72 by SDAI and Boolean index 2.Achievement rates for low disease activity status by SDAI and CDAI at weeks 24, 48 and 72 3.Changes of ACR20,50,70 over time 4.Changes of ACR-hybrid, SDAI, CDAI, and DAS28 over time 5.Changes of sigmaSDAI, sigmaCDAI, sigmaDAS28, vdH-modified TSS score, JSN score and erosion score from baseline and achievement rate of structural remission at weeks 24, 48 and72 6.Changes of physical function (EQ-5D, full HAQ) over time and functional remission rates at weeks 24, 48 and 72 7.Safety (incidence and types of adverse events, severe adverse events, adverse drug reactions, and serious adverse drug reactions) 8.Identification of prognostic factor for clinical remission, functional remission, and normalization of physical function