spondyloarthritis
Conditions
Interventions
axial spondyloarthritis:none
Sponsors
Department of Rheumatology and Immunology, the First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who meet all the following conditions can be selected: (1) = 18 years old, male or female; (2) understand the steps and contents of the trial and voluntarily sign an informed consent form to agree to participate in the trial. (3) accorded with the revised New York standard of ankylosing spondylitis in 1984 or ASAS's classification of axial SpA in 2009, and there were no changes of bilateral grade ? and above or unilateral grade ? and above sacroiliitis on CT film of sacroiliac joint. (4) SpA was in the active stage at the time of screening: magnetic resonance imaging (MRI) showed that unilateral or bilateral sacroiliac joint active inflammation (in accordance with the definition of ASAS [1]), and peripheral blood CRP > normal upper limit, and BASDAI = 4 (VAS score) or ASDAS = 2.1. (5) two kinds of NSAID treatments have been used in the past 4 weeks (the maximum dose of NSAID in the prescription or the maximum dose that the patient can tolerate), but the curative effect is not good (to be judged by the clinician), and the dose of NSAID is stable for at least 2 weeks; (6) No hormone, csDMARDs or Chinese herbal medicine has been used for at least 4 weeks; (7) the results of laboratory tests meet the following requirements: square Hb = 85g/L. 3.5x109qL = white blood cell count = 10x109Gy / L, platelet = lower limit of normal value, ALT, TBil = twice of upper limit of normal valueSCr = upper limit of normal value; negative pregnancy test for women of childbearing age; both men and women agree to take effective contraceptive measures during and within 6 months after the end of the trial; (8) patients can be followed up on a regular basis.
Exclusion criteria
Exclusion criteria: Patients who met any of the following conditions could not be selected: (1) patients who had used biological agents or small molecular targeted drugs, such as TNF- a inhibitors, IL-17 antagonists, trofamethib, etc.; (2) met one of the following conditions related to tuberculosis: a) positive interferon-gamma release test (IGRA); b) had a history of active tuberculosis. During screening or within 3 months before screening, chest X-rays found evidence of current or previous tuberculosis (positive and lateral radiographs are recommended); c) recent close contact with patients with active tuberculosis; or people at high risk and / or low immune function (e.g. long-term use of corticosteroids, immunosuppressive drugs, and any signs of latent tuberculosis infection). (3) at the time of screening, they were in the acute attack of acute or chronic infection; (4) during or within 6 months before the screening, they suffered from invasive fungal infections (e.g. histoplasmosis, coccidiomycetes, Candida, Aspergillus, blastomyces, pneumocystis, etc.); or opportunistic bacterial infections (e.g. bacterial, viral or other infections, including Legionella and Listeria). (5) having a history of severe liver disease or history; screening positive for hepatitis B or C, indicating viral hepatitis, and only healthy carriers with positive HBs-Ag were not regarded as exclusion criteria, and whether the patient was selected was decided by the researchers; (6) had a history of artificial joint infection, or had suspected artificial joint infection that had been treated with antibiotics and the artificial joint had not been removed. (7) Organ transplant was performed at the time of screening or within 6 months prior to screening; (8) suffering from other autoimmune diseases whose symptoms and signs are expected to affect the evaluation of therapeutic drugs, such as psoriasis, uveitis and / or IBD symptoms in the last 6 months; (9) suffering from SLE or lupus-like syndrome, multiple sclerosis or central nervous system demyelinating disease or history. (10) suffering from congestive heart failure or history(11) malignant tumors (except skin squamous cell carcinoma or basal cell carcinoma with no evidence of recurrence, or cervical carcinoma in situ) at the time of screening or within 5 years before screening; AIDS patients or HIV-infected persons; (12) a history of lymphoproliferative diseases such as lymphoma, or a possible lymphoproliferative disease in symptoms and signs; or splenomegaly (= subcostal 2cm). (13) suffering from severe, progressive, uncontrolled diseases of important organs and systems, and other situations that other researchers believe that patients should not participate in this trial; (14) there are situations that may affect patients' compliance (such as long-term business trips or vacations, planning to move, suffering from mental illness, lack of motivation to participate, etc.)..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS 20 improvement criteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS 40 improvement criteria;BASDAI;BASFI;Acute phase reactant laboratory assessment of CRP (mg/L) and ESR (mm/h); | — |
Countries
Beijng
Contacts
Public ContactHuang Feng
Department of Rheumatology and Immunology, the First Medical Center of PLA General Hospital
Outcome results
None listed