Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
NCT ID: NCT02201043
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
197 participants
INTERVENTIONAL
2013-02-28
2015-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Thalidomide 150mg
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
Thalidomide 150mg
Thalidomide 100mg
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
Thalidomide 100mg
Placebo
Placebo po.
Placebo
Interventions
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Thalidomide 150mg
Thalidomide 100mg
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (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
* (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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Other Identifiers
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SLDA-201
Identifier Type: -
Identifier Source: org_study_id