DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Shanghai Pharmaceuticals Holding Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Thalidomide 150mg (Drug); Thalidomide 100mg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Shanghai Pharmaceuticals Holding Co., Ltd


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.

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)

Secondary outcome:

Change of ASDAS score

Change of ASDAS score

Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)

Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)

Mean change from baseline in back pain using a Visual Anolog Scale(VAS)

Morning stiffness

Number of Peripheral swollen joints

Number of Peripheral joint tenderness

Chest expansion



Schober test



Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- (1) Active Ankylosing Spondylitis, Age 18-65, both outpatient or inpatient, both


- (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


- (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.

Locations and Contacts

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, China; Recruiting
zhijun li, MD, Phone: 13955289810, Email: lizhijun@medmail.com.cn
zhijun Li, MD, Principal Investigator

The General Hospital of People's Liberation Army, BeiJing, Beijing 100853, China; Recruiting
Feng Huang, MD, Phone: 0086-010-55499013, Email: fhuang1964@yahoo.com
Feng Huang, MD, Principal Investigator

Changhai Hospital, Shanghai, Shanghai 200433, China; Recruiting
dongbao zhao, MD, Phone: 15918195628, Email: dongbaozhao@163.com
dongbao zhao, MD, Principal Investigator

Shanghai Guanghua Hospital, Shanghai, Shanghai 200052, China; Recruiting
dongyi he, MD, Phone: 15800300800, Email: dongyih@medmail.com.cn
dongyi he, MD, Principal Investigator

Zhongshan Hospital Fudan University, Shanghai, Shanghai 200032, China; Recruiting
lindi jiang, MD, Phone: 13701973875, Email: jianglindi@medmail.com.cn
lindi jiang, MD, Principal Investigator

Xijing Hospital, XiAn, Shanxi 710032, China; Recruiting
Yanna Ba, MD, Phone: 15029215869, Email: bayanna@163.com
Yanna Ba, MD, Principal Investigator

Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072, China; Recruiting
bin zhou, MD, Phone: 13908029299, Email: Bingb2917@126.com
bin zhou, MD, Principal Investigator

West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China; Recruiting
yi liu, MD, Phone: 18980602061, Email: yi2006liu@163.com
yi liu, MD, Principal Investigator

The Xinjiang Uygur Autonomous Region people's Hospital, Wulumuqi, Xinjiang 830001, China; Recruiting
lijun Wu, MD, Phone: 13999265917, Email: wulj330@126.com
lijun wu, MD, Principal Investigator

Additional Information

Starting date: February 2013
Last updated: July 23, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017