ankylosing spondylitis
Conditions
Interventions
Full-dose group:Treatment of adalimumab
Reduced-dose group:Treatment of adalimumab
Sponsors
First Affiliated Hospital of Chengdu Medical College,Chengdu,China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1 ) voluntarily participate in the study, and can provide written informed consent ( ICF ), and can comply with the requirements of the study program to visit, with the acceptance of the research center staff for subcutaneous injection ; 2 ) Men or women aged = 18 years and = 70 years at the time of screening ; 3 ) Patients with ax-SpA according to ASAS classification criteria ; 4 ) The patients were treated with a standard dose of adalimumab in the study and achieved low disease activity for more than 6 months ( BASDAI < 4, = 6 months ) ;
Exclusion criteria
Exclusion criteria: If any of the following criteria is met, the subjects cannot be included in this study : 1 ) other types of tumor necrosis factor-a inhibitors are being used ; 2 ) Allergic to the ingredients of this product ; or have a history of allergic reaction to tumor necrosis factor ; 3 ) active tuberculosis or other serious infectious diseases ; 4 ) patients with moderate to severe heart failure ( NYHA grade III / IV ) ; 5 ) Patients with malignant tumors ; 6 ) pregnant or lactating women ; 7 ) The medication regimen had been adjusted before baseline, non-standard dose treatment ; 8 ) Vaccinated live vaccine within 4 weeks before screening, or intended to vaccinate live vaccine during the study period ; 9 ) Other situations judged by the researchers to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with low disease activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| relapsing rate ;ASDAS;ASQoL;BASFI;ESR;CRP; | — |
Countries
China
Contacts
Public ContactWantai Dang
First Affiliated Hospital of Chengdu Medical College,Chengdu,China
Outcome results
None listed