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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-TRC-13003449
Date of registration: 2013-06-07
Prospective Registration: Yes
Primary sponsor: The General Hospital of People's Liberation Army
Public title: A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis
Scientific title: A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis
Date of first enrolment: 2013-04-25
Target sample size: Thalidomide 150mg:80;Thalidomide 100mg:80;Control group:40;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=6110
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  II (Phase II study)
Countries of recruitment
China
Contacts
Name: Huang Feng   
Address:  28 Fuxing road, Beijing 213018
Telephone: +86 010-55499013
Email: fhuang1964@yahoo.com
Affiliation:  The General Hospital of People's Liberation Army
Name: Jia Wei   
Address:  4th Building, 898 Halei Road, Shanghai, China 201203
Telephone: +86 021-61871700-8130
Email: jiaw@pharm-sh.com.cn
Affiliation:  Central Research Institute, Shanghai Pharmaceuticals Holding Co., Ltd.
Key inclusion & exclusion criteria
Inclusion criteria: (1) Active Ankylosing Spondylitis, Aged 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.


Age minimum: 18
Age maximum: 65
Gender: Both
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Thalidomide 150mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd, po., to the end;Thalidomide 100mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end;Control group:Placebo po.;
Primary Outcome(s)
Number of Subjects Achieving Assessment in Ankylos;
Secondary Outcome(s)
Change of ASDAS score at week 12;Change of ASDAS score at week 24;Mean change from baseline in Bath Ankylosing Spond;Mean change from baseline in Bath Ankylosing Spond;Mean change from baseline in Nocturnal Pain using;Mean change from baseline in back pain using a VAS;Morning stiffness;Number of Peripheral swollen joints;Number of Peripheral joint tenderness;Chest expansion;ESR;CRP;Schober test;Scoliosis;
Secondary ID(s)
Source(s) of Monetary Support
Self-financing
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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