Pilot study for molecular remission of rheumatoid arthritis with JAK inhibitors

JRCT ID: jRCTs031220473

Registered date:28/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 28/11/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administration of baricitinib

Outcome(s)

• Primary Outcome: Proportion of patients who achieved at least one molecular class remission (WB transcript or serum protein) at Week 12

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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
->= 6/68 Tender Joint Count
->= 6/66 Swollen Joint Count
-High sensitivity C-reactive protein (hsCRP) >= 0.6mg/dL
-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

Exclude 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

Related Information

• Primary Sponsor: Kaneko Yuko
• Source(s) of Monetary Support: Eli Lilly Japan K.K.