spondyloarthritis(SpA)/ankylosing spondylitis(AS)
Conditions
Interventions
AS+peripheral arthritis:MTX
AS+peripheral arthritis:placebo
AS:MTX
AS:placebo
nr-axial SpA+peripheral arthritis:MTX
nr-axial SpA+peripheral arthritis:placebo
nr-xial SpA:MTX
nr-xial SpA:placebo
Sponsors
Department of rheumatology of the Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women 18 years of age or older and less than 45 years old; 2. Axial SpA classified according to the ASAS classification for axial SpA at least 3 months prior to first study agent administration and symptoms of active disease at screening and baseline; 3. Treatment failure to at least one NSAID of at least one month duration at the maximal recommended or tolerated anti-inflammatory dose, unless NSAIDs are contraindicated; 4. Symptom duration sustained >3 months and =2.1; 6. Women of childbearing consent to take adequate contraceptive precautions; 7. Previous conventional synthetic DMARD therapy discontinued for at least 1 month and biological synthetic DMARDs discontinued for at least 3 months; 8. Peripheral arthritis of 44 joints should be checked by clinical evaluation and confirmed by ultrasonography; 9. Willing and able to give informed consent and could be followed up.
Exclusion criteria
Exclusion criteria: 1. Receiving corticosteroids within 3 months or currently; 2. Treatment of Taditional chinese medicine in less than 3 months; 3. With other rheumatic autoimmune diseases: such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, etc. If autoimmuneantibodies such as antinuclear antibody is positive, the possibility of SLE and other CTDs should be carefully checked. 4. Patients with a defect associated with any of the following: (1) ALT, AST, 1.5 times more than normal ceiling, total bilirubin 1.5 times greater than the upper limit of normal, serum creatinine greater than the upper limit of normal value; (2) WBC < 3*10^9/L or HGB < 85 g/L or PLT < 100*10^9/L; (3) has serious cardiovascular, renal, and other important organs and blood, endocrine system disease, malignant tumor and history; (4) pregnant women, nursing mothers, and the recent plan to conception of male or female; (5) immunodeficiency, not control the infection and active disease in patients with gastrointestinal tract; (6) relevant experimental drug allergy history; (7) has a history of heavy drinking, (8) psychiatric patients; 5. Recent participation in other clinical trials within 3 months; 6. Other conditions that is considered to be not suitable for participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement assessed by The ASDAS wich will be divided to important or major important improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS 20 improvement criteria;ASAS 40 improvement criteria;ASAS partial remission criteria;ASAS 5/6 improvement criteria;Patient global assessment of disease activity(PGA);Physician global assessment of disease activity;BASDAI;BASFI;Number of swollen and/or pain joints(44 joints joints according to the ASAS handbook,0-10NRS scale);Acute phase reactant laboratory assessment of CRP (mg/l) and ESR (mm/h);Maastricht Ankylosing Spondylitis Enthesitis Score (MASES);Changes of sacroiliac joint evaluated by MRI of the SIJ-SPARCC scoring methdology between baseline to weeks 24;Changes of peripheral arthritis evaluated by clinical evaluation and ultrasound between baseline to weeks 24; | — |
Countries
China
Contacts
Public ContactHUANG FENG
Outcome results
None listed