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
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.
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 scoreChange 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 ESR CRP Schober test Scoliosis
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
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
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