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

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · Jul 23, 2014

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.