A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-13003449
• Date of registration: 2013-06-07
• Prospective Registration: No
• Primary sponsor: The General Hospital of People's Liberation Army
• Public title: A multicenter, randomized, double-blind, placebo-controlled, 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: 2013-04-25
• Target sample size: Thalidomide 150mg:80;Thalidomide 100mg:80;Control group:40;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=6110
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: II (Phase II study)

Countries of recruitment

China

Contacts

• Name: Huang Feng
• Affiliation: The General Hospital of People's Liberation Army

• Name: Jia Wei
• Affiliation: Central Research Institute, Shanghai Pharmaceuticals Holding Co., Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: (1) Active Ankylosing Spondylitis, Aged 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.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Thalidomide 150mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd, po., to the end;Thalidomide 100mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end;Control group:Placebo po.;

Primary Outcome(s)

Number of Subjects Achieving Assessment in Ankylos;

Secondary Outcome(s)

Change of ASDAS score at week 12;Change of ASDAS score at week 24;Mean change from baseline in Bath Ankylosing Spond;Mean change from baseline in Bath Ankylosing Spond;Mean change from baseline in Nocturnal Pain using;Mean change from baseline in back pain using a VAS;Morning stiffness;Number of Peripheral swollen joints;Number of Peripheral joint tenderness;Chest expansion;ESR;CRP;Schober test;Scoliosis;

Source(s) of Monetary Support

Self-financing