The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- The number of patient exhibited an ASAS 20 response to treatment at week 20.
研究概览
简要总结
Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.
详细描述
Forty consecutive patients will be recruited from the rheumatology clinic of the Prince of Wales Hospital with AS meeting the modified New York criteria with active disease as defined (see below). They will be randomized to receive MTX 7.5 mg/week initially with a weekly 2.5mg increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic acid 5mg daily for a period of 16 week. After 16 weeks, all patients will receive infliximab at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with MTX 15 mg/week or placebo. Thereafter, they will be followed up at week 30, 38 weeks. MRI changes in the sacroiliac joints (SI) before and after infliximab treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled the AS:meeting the modified New York criteria
- •Active disease despite NSAID treatment defined as:
- •Spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains
- •Back pain
- •Patient global assessment of disease activity
- •Physical function
- •Informed consent
排除标准
- •Complete ankylosis of the spine
- •On sulphasalazine
- •Previous use of TNF inhibitors
- •Multiple use of NSAIDS
- •Prednisolone > 10mg/day
- •Changes of NSAIDS or dose of prednisolone within 2 weeks of baseline
- •Little or no ability for self-care
- •Received intra-articular,intramuscular, or intravenous corticosteroids in the 4 weeks before screening
- •Infected joint prosthesis during the previous 5 years
- •Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
- •Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis
- •Active tuberculosis requiring treatment within the previous 3 years
- •Opportunistic infections such as herpes zoster within the previous 2 months
- •Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection
- •Known hypersensitivity to murine proteins
- •Current signs or symptoms of severe,progressive,or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
- •A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie,lymph nodes in the posterior triangle or the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly;
- •Any known malignant disease except basal cell carcinoma currently or in the past 5 years.
- •A hemoglobin level < 8.5 gm/dl, a white blood cell count < 3.5 × 10^9/liter, a platelet count < 100 × 10^9/liter, a serum creatinine level > 150 µmol/l, serum transaminase levels 1.25 times the upper limit of normal, or alkaline phosphatase levels > 2 times the upper limit of normal.
研究组 & 干预措施
2
placebo with infliximab
干预措施: Infliximab and MTX (Drug)
结局指标
主要结局
The number of patient exhibited an ASAS 20 response to treatment at week 20.
时间窗: wk52
次要结局
- Proportion of patients with 50% and 70% improvement in disease activity.Patient global assessment of disease activity and pain;BASFI;early morning stiffness;physician global assessment of disease activity.Changes in the pre and post infusion MRI.(wk52)
研究者
Lai-Shan Tam
Professor
Chinese University of Hong Kong