NCT01895764已完成4 期
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 22
- 主要终点
- presence or absence of antibodies against adalimumab
研究概览
简要总结
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject 18 years of age or older
- •Able and willing to give written informed consent and to comply with the requirements of the study protocol
- •Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria
- •Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs
排除标准
- •Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy.
- •Previous methotrexate treatment, not stopped 3 month before inclusion
- •Surgery scheduled during study
- •Female subject without method of contraception
- •Contraindication to adalimumab or methotrexate
研究组 & 干预措施
Adalimumab + Methotrexate
Experimental
adalimumab 40mg every 2 weeks and methotrexate 10mg per week
干预措施: Methotrexate (Drug)
Adalimumab
Active Comparator
adalimumab 40mg every 2 weeks
干预措施: Adalimumab (Drug)
Adalimumab + Methotrexate
Experimental
adalimumab 40mg every 2 weeks and methotrexate 10mg per week
干预措施: Adalimumab (Drug)
结局指标
主要结局
presence or absence of antibodies against adalimumab
时间窗: 6 months
次要结局
- Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)(6 months)
- Change from baseline of T and B cells concentrations.(6 months)
- Change from baseline of "APRIL" and "TNF alpha" concentrations(6 months)
研究者
研究点 (22)
Loading locations...
相似试验
Unknown
2 期
Adalimumab Plus Methotrexate for the Treatment of Pediatric UveitisUveitisNCT04588818Sun Yat-sen University30
已完成
4 期
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid ArthritisRheumatoid ArthritisNCT00420927Abbott1,032
终止
2 期
Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)Ulcerative ColitisNCT01716039Alimentiv Inc.22
进行中（未招募）
1 期
Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosanteEUCTR2012-004939-23-FRCHRU de TOURS110
已完成
3 期
Quality of Life Study With Adalimumab in Rheumatoid ArthritisRheumatoid ArthritisNCT00234936Abbott200