Clinical trial NCT02201043: Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
thalidomide
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
timeFrame: week 12
Secondary outcomes:
measure: Change of ASDAS score
timeFrame: week 12
measure: Change of ASDAS score
timeFrame: week 24
measure: Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: week 24
measure: Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)
timeFrame: week 24
measure: Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)
timeFrame: week 24
measure: Mean change from baseline in back pain using a Visual Anolog Scale(VAS)
timeFrame: week 24
measure: Morning stiffness
timeFrame: week 24
measure: Number of Peripheral swollen joints
timeFrame: week 24
measure: Number of Peripheral joint tenderness
timeFrame: week 24
measure: Chest expansion
timeFrame: week 24
measure: ESR
timeFrame: week 24
measure: CRP
timeFrame: week 24
measure: Schober test
timeFrame: week 24
measure: Scoliosis
timeFrame: week 24
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: BeiJing
country: China
facility: The General Hospital of People's Liberation Army
state: Beijing
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Guanghua Hospital
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: XiAn
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Wulumuqi
country: China
facility: The Xinjiang Uygur Autonomous Region people's Hospital
state: Xinjiang
Study officials:
References: