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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02201043
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
Shanghai Pharmaceuticals Holding Co., Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Thalidomide 150mg Drug: Thalidomide 100mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Study Start Date : February 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arm Intervention/treatment
Active Comparator: Thalidomide 150mg
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/ the end
Drug: Thalidomide 150mg
Other Names:
  • Thalomid
  • Fan Ying Ting

Active Comparator: Thalidomide 100mg
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/ the end
Drug: Thalidomide 100mg
Other Names:
  • Thalomid
  • Fan Ying Ting

Placebo Comparator: Placebo
Placebo po.
Drug: Placebo

Primary Outcome Measures :
  1. Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Change of ASDAS score [ Time Frame: week 12 ]
  2. Change of ASDAS score [ Time Frame: week 24 ]
  3. Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: week 24 ]
  4. Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI) [ Time Frame: week 24 ]
  5. Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS) [ Time Frame: week 24 ]
  6. Mean change from baseline in back pain using a Visual Anolog Scale(VAS) [ Time Frame: week 24 ]
  7. Morning stiffness [ Time Frame: week 24 ]
  8. Number of Peripheral swollen joints [ Time Frame: week 24 ]
  9. Number of Peripheral joint tenderness [ Time Frame: week 24 ]
  10. Chest expansion [ Time Frame: week 24 ]
  11. ESR [ Time Frame: week 24 ]
  12. CRP [ Time Frame: week 24 ]
  13. Schober test [ Time Frame: week 24 ]
  14. Scoliosis [ Time Frame: week 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02201043

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China, Anhui
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
China, Beijing
The General Hospital of People's Liberation Army
BeiJing, Beijing, China, 100853
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Shanghai Guanghua Hospital
Shanghai, Shanghai, China, 200052
Changhai Hospital
Shanghai, Shanghai, China, 200433
China, Shanxi
Xijing Hospital
XiAn, Shanxi, China, 710032
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
China, Xinjiang
The Xinjiang Uygur Autonomous Region people's Hospital
Wulumuqi, Xinjiang, China, 830001
Sponsors and Collaborators
Shanghai Pharmaceuticals Holding Co., Ltd
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Responsible Party: Shanghai Pharmaceuticals Holding Co., Ltd Identifier: NCT02201043    
Other Study ID Numbers: SLDA-201
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Shanghai Pharmaceuticals Holding Co., Ltd:
ankylosing spondylitis
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antifungal Agents