NCT02201043已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 9
- 主要终点
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
研究概览
简要总结
- Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Thalidomide 150mg
Active Comparator
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
干预措施: Thalidomide 150mg (Drug)
Thalidomide 100mg
Active Comparator
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
干预措施: Thalidomide 100mg (Drug)
Placebo
Placebo Comparator
Placebo po.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
时间窗: week 12
次要结局
- CRP(week 24)
- Schober test(week 24)
- Scoliosis(week 24)
- 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)
研究者
研究点 (9)
Loading locations...
相似试验
Unknown
4 期
A Study of Thalidomide in the Treatment of Refractory Uremic PruritusHaemodialysisUremic PruritusThalidomideNCT05525234RenJi Hospital40
终止
2 期
Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom MacroglobulinemiaWaldenstrom MacroglobulinemiaNCT01779167Weill Medical College of Cornell University4
已完成
2 期
Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple MyelomaMultiple MyelomaNCT00657488Celgene400
已完成
3 期
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1Complex Regional Pain Syndrome, Type 1NCT00166452Mayo Clinic7
Unknown
2 期
Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular CancerLiver CancerNCT00006198National Center for Research Resources (NCRR)