Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
1 other identifier
interventional
197
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2013
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 20, 2015
November 1, 2015
2 years
July 23, 2014
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
week 12
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Study Arms (3)
Thalidomide 150mg
ACTIVE COMPARATORThalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
Thalidomide 100mg
ACTIVE COMPARATORThalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
Placebo
PLACEBO COMPARATORPlacebo po.
Interventions
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
The General Hospital of People's Liberation Army
Beijing, Beijing Municipality, 100853, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Guanghua Hospital
Shanghai, Shanghai Municipality, 200052, China
Changhai Hospital
Shanghai, Shanghai Municipality, 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
Ürümqi, Xinjiang, 830001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
July 25, 2014
Study Start
February 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 20, 2015
Record last verified: 2015-11