Rheumatoid arthritis
Conditions
Interventions
None listed
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 our study. 1.A patient who fulfills the 2010 ACR/EULAR classification criteria of RA (SDAI>11 or CDAI>10) 2.A patient who have equal or more than 2 swollen joints and equal or more than 2 tender joints 3.A patient who is older than 20 years old and provides a written informed consent to join in this study 4.A patient who have never received biological disease-modifying anti-rheumatic drugs (DMARDs) 5.A patient who starts, adds, or changes a DMARD or biological DMARD 6.A patient who can be followed regularly in the outpatient clinic
Exclusion criteria
Exclusion criteria: A patient who has any of the following will be excluded from our study. 1.When a patient withdraws his or her consent. 2.When a doctor judges a patient is not appropriate to join the study. 3.When a patient is under breastfeeding or pregnant. 4.When a doctor judges a patient cannot be followed regularly in the outpatient clinic for 72 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for our study is to identify prognostic factors for physical function and structural damage at week 72 in RA patient with moderate or high disease activity who receive treatment with T2T strategy. The main outcome measures are SDAI, CDAI, HAQ, EQ-5D and vdH-modified Total Sharp Score. We compare these outcome measures between the T2T-achieved group and not-achieved group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Remission or Low disease activity status achievement rates in clinical practice 2.Implementation rate of T2T 3.Obstacles for implementation of T2T strategy | — |
Countries
Japan
Contacts
Public ContactMarie Yajima
Tokyo Medical and Dental University Department of Pharmacovigilance
Outcome results
None listed