Rheumatoid arthritis
Conditions
Interventions
Administration of baricitinib
Sponsors
Kaneko Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -At least 20 years of age -Diagnosed adult-onset RA as defined by the ACR/EULAR 2010 Criteria for the Classification of rheumatoid arthritis -Inadequate response to MTX: Use over 12 weeks use Stable dosage of 7.5-16 mg/week for over 8 weeks before baseline DAS28 ESR >=32 -Have not used csDMARD other than MTX within 12 weeks prior to visit 2 (start of the baricitinib) -Can read, understand, and give written informed consent
Exclusion criteria
Exclusion criteria: -Prior use of biologics or JAK inhibitors -Active tuberculosis -Neutrophil count <500 cells/mm3 -Pregnant or nursing at the time of study entry -Serious infection -Severe renal dysfunction -Lymphocyte count <500 cells/mm3 -Hemoglobin level <8g/dL. -Regarded as inadequate for the study enrollment by the physician for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved at least one molecular class remission (WB transcript or serum protein) at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Proportion of patients who achieved at least one molecular class remission at Week 24 -Proportion of patients who achieved ACR20, 50, 70 at Week12, 24 -Proportion of improvement of ACR core set, disease activity score (DAS, CDAI), health questionnaire (HAQ-DI) at Week12, 24 -Proportion of improvement of PRO at Week12, 24 -Proportion of patients who achieved in clinical remission and functional remission at Week12, 24 | — |
Contacts
Public ContactJun Kikuchi
Keio University School of Medicine (Keio University Hospital)
Outcome results
None listed