Rheumatoid Arthritis
Conditions
Interventions
A:Iguratimod combination therapy with JAK inhibitor
B:JAK inhibitor
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 18 and 65; 2. Weight not less than 40kg, and less than 90kg; 3. Meet ACR 1987 or ACR/EULAR 2010 RA classification standards; Patients with a definite diagnosis of rheumatoid arthritis (RA); 4. Moderate to high disease activity at screening time (DAS28 > 3.2); 5. Joint function I-III grade; 6.Previous medication: 6.1 Patients who have previously used JAKi and biological agents should stop using them for three months before inclusion; 6.2 csDMARDs: CsDMARDs are limited to the following categories: Iguratimod (IGU), methotrexate (MTX), leflunomide (LEF), salicylazosulfapyridine (SASP), hydroxychloroquine (HCQ), tacrolimus (TAC), cyclosporine, azathioprine, cyclophosphamide, tripterygium wilfordii preparation and other commonly used Chinese patent medicine (mainly Tripterygium wilfordii preparation) and Chinese medicine decoction for the treatment of RA. 6.2.1 Patients who have previously used unknown anti-rheumative drugs or irregularly used csDMARDS and meet other admission criteria should be labeled as "Chinese herbal medicine" in their previous medication, and the duration from x month 1 to X + March 1 should be recorded for the purpose of identification and separate analysis of this group. 6.2.2 Patients who have used csDMARDS for less than 3 months with poor response or intolerance, and meet other admission criteria, should fill in this drug in the previous medication, and record the start and end time from X month 1 to X + March 1. Easy to identify and separate analysis. 6.2.3 Patients who had been treated with one or more traditional slow-acting antirheumatic drugs (csDMARDs) for >= 3 months with poor response or intolerance, and had DAS28 > 3.2 at the time of screening. 6.2.4 If the subjects are using csDMARDs at the time of screening, they shall be cleaned before randomization. The cleaning period shall be as follows: Except for LEF, all csDMARDs have been discontinued for at least 4 weeks before randomization, and LEF has been discontinued for at least 12 weeks before randomization, except for those who have been discontinued for at least 4 weeks after receiving standard coreenamine therapy or activated carbon elution, and should not be taken after randomization. The commonly used Chinese patent medicine (mainly tripterygium wilfordii preparation) and Chinese medicine decoction for RA should be stopped for 2 weeks before random administration. 7. If Technetium [99Tc] Methylenediphosphonate Injection (99Tc-Mdp) is used during hospitalization, blood and urine samples should be collected 24 hours before discontinuation. 8. Understand the purpose and procedure of the test, and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergy to relevant test drugs; 2. Subjects have received live vaccine recently or plan to use any live vaccine during the study; 3. Before the screening, have serious cardiovascular disease, kidney, liver, and other important organs damage or serious blood system, endocrine system disease, aplastic anemia, hyperthyroidism crisis, etc.), HIV/AIDS, or history of malignant tumor chemotherapy, hysterectomy, organ or bone marrow transplantation and other connective tissue disease (systemic lupus erythematosus (sle) and sjogren's syndrome, etc.); 4. High-risk pulmonary patients (1) Chest CT findings /TB-SPOT findings within 6 months suggested tuberculosis; (2) Chest CT results within 6 months indicated pulmonary interstitial fibrosis and forced vital capacity (FVC) 5mm patient. Nodule diameter <5mm were judged by the investigator, respiratory surgeon, or thoracic surgeon. 5. ALT, AST 1.5 times higher than the upper limit of normal, creatinine more than 1.5mg/dl or 135umol/L; 6. WBC < 3 x 10^9 / L, HGB < 85 g/L, PL < 100 x 10^9 / L; 7. Pregnant or lactating women and men or women who intend to become pregnant in the near future; 8. A history of heavy drinking; 9. Mental patients; 10. Participated in clinical trials of other new drugs within three months; 11. Other conditions in which the investigator considers the patient unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 repsonse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28-ESR;SDAI;CDAI;Boolean ease rate;HAQ;PtGA;PhGA;DSA28-ESR response rate;ESR;CRP; | — |
Countries
China
Contacts
Public ContactShu Qiang
Qilu Hospital of Shandong University
Outcome results
None listed