Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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 once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
• Treatments: Thalidomide; Tolnaftate

Criteria

Inclusion Criteria:

• (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 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 (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.