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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02201043
Other study ID # SLDA-201
Secondary ID
Status Completed
Phase Phase 2
First received July 23, 2014
Last updated November 17, 2015
Start date February 2013
Est. completion date February 2015

Study information

Verified date November 2015
Source Shanghai Pharmaceuticals Holding Co., Ltd
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

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


Intervention

Drug:
Thalidomide 150mg

Thalidomide 100mg

Placebo


Locations

Country Name City State
China The General Hospital of People's Liberation Army BeiJing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China Sichuan Provincial People's Hospital Chengdu Sichuan
China West China Hospital of Sichuan University Chengdu Sichuan
China Changhai Hospital Shanghai Shanghai
China Shanghai Guanghua Hospital Shanghai Shanghai
China Zhongshan Hospital Fudan University Shanghai Shanghai
China The Xinjiang Uygur Autonomous Region people's Hospital Wulumuqi Xinjiang
China Xijing Hospital XiAn Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) week 12 No
Secondary Change of ASDAS score week 12 No
Secondary Change of ASDAS score week 24 No
Secondary Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) week 24 No
Secondary Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI) week 24 No
Secondary Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS) week 24 No
Secondary Mean change from baseline in back pain using a Visual Anolog Scale(VAS) week 24 No
Secondary Morning stiffness week 24 No
Secondary Number of Peripheral swollen joints week 24 No
Secondary Number of Peripheral joint tenderness week 24 No
Secondary Chest expansion week 24 No
Secondary ESR week 24 No
Secondary CRP week 24 No
Secondary Schober test week 24 No
Secondary Scoliosis week 24 No
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