Last updated: March 26, 2023
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Not Recruiting
Phase
4
Condition
Arthritis And Arthritic Pain
Dermatomyositis (Connective Tissue Disease)
Joint Injuries
Treatment
N/AClinical Study ID
NCT05803135
NFEC-2022-282
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients who meet the following inclusion criteria will be eligible to participate in thestudy:
- Male or female aged 18-65 years old;
- Weight not less than 40kg;
- Since the diagnosis of RA, the course of disease was ≥6 months;
- Patients who meet RA standards in 1987 and 2010 ;
- RA patients with moderate to high disease activity (DAS28 > 3.2) at the time ofscreening;
- Active RA (≥6 joints swelling [66 joints count]; ≥Tenderness of 6 joints [68 jointcounts]; ESR>28 mm/h or C-reactive protein (CRP) >1.0 mg/dL);
- Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, butnot tsDMARDs;
- Previous use of any JAK inhibitor was discontinued for six months before enrollment;
- For patients who have used DMARDs, the washout criteria must be met;
- Written informed consent;
Exclusion
Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study:
- Pregnant or lactating women;
- Platelet count < 10^9/L, or white blood cell < 310^9/L, or absolute neutrophil count < 1.210^9/L, or Hemoglobin < 9 g/dL or hematocrit <30%;
- According to Cockcroft-Gault, the glomerular filtration rate was ≤40 ml/min.
- ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L;
- Subjects with serious cardiovascular, renal, hematologic or endocrine diseases;
- A history of autoimmune rheumatic diseases other than Sjogren's syndrome;
- Subjects with uncontrolled infection;
- Subjects receiving live vaccines within 6 weeks prior to study entry;
- history of alcohol or drug abuse and abstinence for less than 6 months prior to thefirst use of the study drug;
- Subjects participating in other clinical study within 3 months prior to study entry;
- Have a history of malignant tumor;
- History of recurrent herpes zoster, diffuse herpes zoster;
- People who are allergic to any of the study drugs;
- Other conditions in which the investigator deemed the patient inappropriate for trialentry;
Study Design
Total Participants: 138
Study Start date:
March 31, 2023
Estimated Completion Date:
December 30, 2025