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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.
Last refreshed on: 7 December 2015
Main ID:  NCT02201043
Date of registration: 23/07/2014
Prospective Registration: No
Primary sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Public title: 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: February 2013
Target sample size: 197
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Key inclusion & exclusion criteria

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

- (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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Drug: Placebo
Drug: Thalidomide 100mg
Drug: Thalidomide 150mg
Primary Outcome(s)
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) [Time Frame: week 12]
Secondary Outcome(s)
Change of ASDAS score [Time Frame: week 12]
Change of ASDAS score [Time Frame: week 24]
Chest expansion [Time Frame: week 24]
CRP [Time Frame: week 24]
ESR [Time Frame: week 24]
Mean change from baseline in back pain using a Visual Anolog Scale(VAS) [Time Frame: week 24]
Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: week 24]
Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI) [Time Frame: week 24]
Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS) [Time Frame: week 24]
Morning stiffness [Time Frame: week 24]
Number of Peripheral joint tenderness [Time Frame: week 24]
Number of Peripheral swollen joints [Time Frame: week 24]
Schober test [Time Frame: week 24]
Scoliosis [Time Frame: week 24]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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