Status:
COMPLETED
Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 on...
Eligibility Criteria
Inclusion
- (1) Active Ankylosing Spondylitis, Age 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
- (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 (BP\<90/50 mmHg) or hypertension (BP\>170/100 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT02201043
Start Date
February 1 2013
End Date
February 1 2015
Last Update
November 20 2015
Active Locations (9)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
2
The General Hospital of People's Liberation Army
Beijing, Beijing Municipality, China, 100853
3
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
4
Shanghai Guanghua Hospital
Shanghai, Shanghai Municipality, China, 200052