Rheumatoid arthritis
Conditions
Interventions
Case series:Case series
Sponsors
Department of Rheumatology and Immunology, Anhui Provincial Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged >=18 years male or female; (2) According to the American College of Rheumatology (ACR) 1987 rheumatoid arthritis diagnostic criteriaAt the time of screening, the disease was in the middle active stage (ESR>=28mm/h or CRP > was normalValue, >=4 joint swelling, >=4 joint tenderness); (3) CONTINUOUS application of GC >=12 weeks; (4) after MTX 7.5-10mg qw combined with GC>=10mg/d (equivalent dose of prednisolone), > was treated for 12 weeks with lack of efficacy (defined as "lack of efficacy, or unsatisfactory effect, or inability to tolerate drug adr withdrawal" according to ACR2015 guidelines for the treatment of rheumatoid arthritis "[4]); (5) No non-steroidal anti-inflammatory drugs (NSAIDs) were used at least 2 weeks before randomization; Or if you are using NSAIDs, the dose should be stable for at least 2 weeks. (6) The pregnancy test of women of childbearing age is negative and they are not in lactation period; Both men and women agree to use effective contraception during the trial period and for a period of six months after its completion; (7) Informed consent has been signed; (8) Subjects can be followed up regularly; (9) The subject can read and complete the evaluation form correctly.
Exclusion criteria
Exclusion criteria: (1) weight >75Kg; (2) Inoculate live (attenuated) virus/bacterial vaccine within 4 weeks before screening; (3) Screening for JAK inhibitors used for rheumatoid arthritis in the previous 3 months); Previous MTX intolerance; (4) into the set of random 2 months before had more serious infections, such as acute hepatitis, pneumonia, acute pyelonephritis), or caused by infection in the hospital, or have used intravenous antibiotics for infection and antifungal drugs or antiviral drugs, but mild infections, such as acute upper respiratory tract infection, urinary tract infection) simple not considered exclusion criteria, whether the patient was decided by the researchers; (5) Screening at the time of acute infection or recurrent infectious diseases, such as respiratory infections (influenza, upper respiratory infection, bronchiectasis, etc.), acute episodes of chronic pyelonephritis, infectious skin wounds, etc.; (6) Screening for opportunistic infections (such as herpes zoster, active cytomegalovirus, mycoplasma, Pneumocystis carinii, histoplasms, aspergillus, mycobacterium except tuberculosis, etc.) in the previous 6 months; (7) A history of artificial joint infection, or suspected artificial joint infection has been treated with antibiotics and the artificial joint has not been removed; (8) With a history of severe liver disease; Or hepatitis B surface antigen positive; Or only hepatitis B core antibody positive, but hepatitis B DNA test positive; Or people with hepatitis C; (9) People living with AIDS or HIV; (10) There is one of the following conditions related to tuberculosis: 1) Has or has a history of active tuberculosis. A chest X-ray (positive and lateral chest radiograph is recommended) must be performed within 3 months prior to screening to find evidence of present or prior tuberculosis infection; 2) Recent close contact with an active TB patient; Or are at high risk and/or immunocompromised (e.g. long-term use of glucocorticoids, immunosuppressive drugs) and have any signs of latent TB infection; 3) PPD test conducted within 3 weeks before screening (5IU tb-ppd was injected into the forearm palmar dermis, and skin induration diameter was measured within 72 hours) : the diameter of induration 15mm; 4) If the PPD trial cannot be conducted, conduct the T-SPOT test: the T-SPOT test is positive, and chest radiograph and clinical evidence suggest that the subject is unfit to participate; (11) has had an organ transplant operation (except for corneal transplants performed at least 3 months before the first study); (12) Screening for previous or present malignancies (except completely resected squamous cell carcinoma of the skin, basal cell carcinoma or carcinoma in situ of the cervix) within 5 years prior to screening; (13) A history of lymphoma or other lymphatic system malignancies or lymphatic proliferative diseases; Or at the time of screening, signs and symptoms suggest the possibility of lymphatic proliferative disease (e.g., lymph node enlargement in the neck, supravicular or axilla); Splenomegaly (>=2cm subcostal); (14) has or has a history of central nervous demyelinating disease such as multiple sclerosis; (15) Has or has had congestive heart failure; (16) is or has been suffering from other autoimmune diseases and is expected to affect the evaluation of the experimental drug; (17) Patients with severe, progressive, uncontrolled cardiovascular, c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR50, 70;VAS;HAQ;Improvement of the duration of morning stiffness;ESR, CRP, RF, anti-CCP; | — |
Countries
China
Contacts
Public ContactWang Li
Department of Rheumatology and Immunology, Anhui Provincial Hospital
Outcome results
None listed