A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

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

Sponsors

Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Source 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.

Overall Status Completed
Start Date February 2013
Completion Date February 2015
Primary Completion Date February 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) week 12
Secondary Outcome
Measure Time Frame
Change of ASDAS score week 12
Change of ASDAS score week 24
Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) week 24
Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI) week 24
Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS) week 24
Mean change from baseline in back pain using a Visual Anolog Scale(VAS) week 24
Morning stiffness week 24
Number of Peripheral swollen joints week 24
Number of Peripheral joint tenderness week 24
Chest expansion week 24
ESR week 24
CRP week 24
Schober test week 24
Scoliosis week 24
Enrollment 197
Condition
Intervention

Intervention type: Drug

Intervention name: Thalidomide 150mg

Arm group label: Thalidomide 150mg

Intervention type: Drug

Intervention name: Thalidomide 100mg

Arm group label: Thalidomide 100mg

Intervention type: Drug

Intervention name: Placebo

Arm group label: Placebo

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Location
facility
The First Affiliated Hospital of Bengbu Medical College | Bengbu, Anhui, 233004, China
The General Hospital of People's Liberation Army | BeiJing, Beijing, 100853, China
Zhongshan Hospital Fudan University | Shanghai, Shanghai, 200032, China
Shanghai Guanghua Hospital | Shanghai, Shanghai, 200052, China
Changhai Hospital | Shanghai, Shanghai, 200433, China
Xijing Hospital | XiAn, Shanxi, 710032, China
West China Hospital of Sichuan University | Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital | Chengdu, Sichuan, 610072, China
The Xinjiang Uygur Autonomous Region people's Hospital | Wulumuqi, Xinjiang, 830001, China
Location Countries

China

Verification Date

November 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Thalidomide 150mg

Arm group type: Active Comparator

Description: Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end

Arm group label: Thalidomide 100mg

Arm group type: Active Comparator

Description: Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo po.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov