1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis. 2. To explore dose-effect relationships of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
197
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The General Hospital of People's Liberation Army
Beijing, Beijing Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
Time frame: week 12
Change of ASDAS score
Time frame: week 12
Change of ASDAS score
Time frame: week 24
Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: week 24
Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)
Time frame: week 24
Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)
Time frame: week 24
Mean change from baseline in back pain using a Visual Anolog Scale(VAS)
Time frame: week 24
Morning stiffness
Time frame: week 24
Number of Peripheral swollen joints
Time frame: week 24
Number of Peripheral joint tenderness
Time frame: week 24
Chest expansion
Time frame: week 24
ESR
Time frame: week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai Guanghua Hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Xijing Hospital
XiAn, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Xinjiang Uygur Autonomous Region people's Hospital
Ürümqi, Xinjiang, China
CRP
Time frame: week 24
Schober test
Time frame: week 24
Scoliosis
Time frame: week 24