rheumatoid arthritis
Conditions
Interventions
Intensive treatment group Period: 24 weeks In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased
discretion and are followed until week 72.
Conventional treatment group Period: 24 weeks In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or b
discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'
discretion and are followed until week 72.
Sponsors
Tokyo Medical and Dental University
Department of Pharmacovigilance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A Patient of rheumatoid arthritis (RA) who meets all of the following will be eligible to the study. 1.A patient who develops arthritis within 2 years before the enrollment and who fulfills the 2010 ACR/EULAR classification criteria for RA 2.A patient who has SDAI>11 3.A patient who is 20 to 70 years old and gives written informed consent 4.A patient who has never received MTX, tacrolimus, and biologics. 5.A patient who can use MTX 6.A patient who has not started any DMARDs within the last 4weeks. 7.A patient who has not received intravenous or intra-articular injection of corticosteroid within the last 4weeks. 8.A patient who has equal or more than 4 swollen joints and equal or more than 4 tender joints (using 66- or 68-joint count, respectively) 9.Patients who meets any of the following criteria 1) positive serology (rheumatoid factor or anti-CCP antibody), 2) typical bone erosion for RA by X-ray, 3) CRP equal or more than 0.8mg/dL
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rates at week 24 by SDAI or Boolean index | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMichi Tanaka
Tokyo Medical and Dental University Department of Pharmacovigilance
Outcome results
None listed