Ankylosing Spondylitis
Conditions
Interventions
Control group:Placebo po.
100mg/qd.po.to the end
Thalidomide 150mg:Thalidomide 25mg/qd.po.2weeks
50mg/qd.po.2weeks
100mg/qd.po.2weeks
150mg/qd, po., to the end
Thalidomide 100mg:Thalidomide 25mg/qd.po.2weeks
Sponsors
The General Hospital of People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Active Ankylosing Spondylitis, Aged 18-65, both outpatient or inpatient, both gender; (2) AS patients after traditional therapy (Using NSAIDs in a stable dose for 1 month, using oral corticosteroids, using NSAIDs for 3 months) still in active stage; (3) Pregnancy test must be negative in the female subjects of childbearing age or wife of the male subjects; (4) Female subjects with fertility during the trial (of 32 weeks) agreed to take a double medically accepted and reliable contraceptive measures, which includes a drug and a non-drug contraceptive measures; if the spouses of male subjects have fertility, agreed to use latex condoms for contraception; (5) Willing to have the treatment according to the plan as well as do the follow-up exam on time; (6) Understand and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Suffering from or have suffered from rheumatoid arthritis, disc prolapse, septic arthritis, diffuse idiopathic skeletal hyperostosis syndrome, iliac dense osteitis, psoriatic arthritis, bowel disease arthritis, Reiter syndrome; (2) Severe AS, spine completely stiff (X-ray class IV) or the disease has been shown to have a shorter survival period; (3) Previously had total hip arthroplasty surgical treatment or appropriate to have the surgery; (4) Previously received anti-TNF therapy; (5) Used leflunomide within 3 months before screening; (6) Severe or persistent infection requires antimicrobial therapy; (7) Hepatitis B surface antigen or hepatitis C antibody test positive; (8) HIV positive or have acquired immunodeficiency syndrome (AIDS) history; (9) Malignancy, lymphoproliferative disease history; (10) Severe diabetes; (11) Resting hypotension (BP170/100 mmHg), and orthostatic hypotension and clinically significant ECG abnormalities; (12) Over the past six months had a stroke, heart attack or other serious cardiovascular disease (including heart failure, unstable angina or life-threatening arrhythmias and coronary artery bypass graft surgery); (13) WBC or neutrophils below the lower limit of normal; (14) Liver dysfunction, AST or ALT l> 2 times the upper limit of normal; (15) Renal dysfunction, Cr>2 times the upper limit of normal; (16) Female subjects or spouses of male subjects have positive pregnancy test or be in the sickling period or intend to fertility or unwilling to take effective contraception; (17) With clinical symptoms of serious drug abuse or alcohol abuse or mental illness history; (18) Participated in any clinical trials of drugs within 3 months before screening; (19) Workers engaged in dangerous (eg drivers, machine operator, high-altitude operations, etc.); (20) A history of deep venous thrombosis or pulmonary embolism; (21) Be allergic to Test drug ingredients (including excipients); (22) Other reasons for not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Achieving Assessment in Ankylos; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of ASDAS score at week 12;Change of ASDAS score at week 24;Mean change from baseline in Bath Ankylosing Spond;Mean change from baseline in Bath Ankylosing Spond;Mean change from baseline in Nocturnal Pain using;Mean change from baseline in back pain using a VAS;Morning stiffness;Number of Peripheral swollen joints;Number of Peripheral joint tenderness;Chest expansion;ESR;CRP;Schober test;Scoliosis; | — |
Countries
China
Contacts
Public ContactHuang Feng
The General Hospital of People's Liberation Army
Outcome results
None listed