radiographic positive axial spondyloarthritis
Conditions
Interventions
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. According with the diagnosis of axial spondyloarthritis (axSpA) by the Assessment of Spondyloarthritis International Society (ASAS); 3. Poor response to non-steroidal anti-inflammatory drugs (NSAIDs) in the past; 4. If the subject is taking background therapy drugs, it should be kept stable; 5. Consent to participate in the research study and sign the informed consent form. Be able to follow the protocal and have the ability to proceed related procedures.
Exclusion criteria
Exclusion criteria: 1. Have a history of lymphoproliferative disease; or suffering from malignant tumor now or have a history of malignant tumor; 2. Have a history of vital organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation; 3. Hepatitis B surface antigen is positive, hepatitis B core antibody is positive (except whose HBV DNA copy number is below the detection limit); hepatitis C antibody, human immunodeficiency virus (HIV) antibody, and anti-syphilis spiral antibody (TP-Ab) are positive (Except whose RPR or TRUST is negative); 4. Patients with active tuberculosis according to the judgement of the investigator, prompted by clinical symptoms, tuberculosis laboratory examinations and/or imaging examination; 5. Those who have a history of allergies to two or more drugs or severe allergies, or allergies to biological products, or those who are likely to be allergic to the investigational product or any ingredient in the investigational product judged by the investigator; 6. Significant abnormalities in liver, kidney function and blood routine examination; abnormal results of other laboratory examination which may influence the subjects' completion of the trial or interfere the results of the trial according to the judgment of the investigator; 7. Recent use of the following biological agents or their biosimilars: prior to baseline, etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; Ustekinumab <8 months; Rituximab or raptiva<12 months; or other biological agents <5 half-lives; 8. Subjects who have received Chinese patent medicine or Chinese medicine decoction for the treatment of axSpA such as Tripterygium wilfordii within 2 weeks before randomization and the whole trial; 9. Subjects who have received spinal surgery or joint surgery within 8 weeks before randomization; 10. Subjects who have unstable extra-articular clinical manifestations according to the investigator's judgement within 4 weeks before randomization; 11. Subjects who have received live vaccination within 4 weeks before randomization or plan to receive live vaccination during the trial; 12. Pregnant or lactating women or subjects who have pregnancy plans during the trial period and within 6 months after stopping taking the medicine; 13. Subjects who have a history of alcohol and/or drug and substance abuse by asking; 14. Subjects who have participated in other clinical trials within 3 months or is currently participating in other clinical trials before randomization; 15. Other reasons that the investigator considers it inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients reaching assessment in ankylosing spondylitis 20; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients reaching assessment in ankylosing spondylitis 20;The proportion of patients reaching assessment in ankylosing spondylitis 40;The proportion of patients reaching assessment in ankylosing spondylitis 5/6;Changes from baseline in Numeric Rating Scale scores by investigators and patients;Changes from baseline in Ankylosing Spondylitis Disease Activity Score-C Reactive Protein;Changes from baseline in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate;Changes from baseline in Bath Ankylosing Spondyliis Disease Activity Index;Changes from baseline in Bath Ankylosing Spondyliis Functional Index;Changes from baseline in Bath Ankylosing Spondylitis Metrology Index;Changes from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score;Work productivity and mobility impairments score;Functional Assessment of Chronic Illness Therapy score;Ankylosing Spondylitis Quality of Life Questionnaire;Columbia-Suicide Severity Rating Scale; | — |
Countries
China
Contacts
Public ContactXiaofeng Zeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed