ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Main trial endpoint
研究概览
简要总结
This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.
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)
盲法说明
multicentre, randomized, double-blind, placebo-controlled study
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria
- •Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS.
- •Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND/OR elevated serum CRP levels.
- •Exclusion criteria:
- •active current infection, severe infections in the last 3 months
- •history of recurrent Herpes zoster or disseminated Herpes simplex
- •immunodeficiency
- •chronic Hepatitis B, C or HIV infection
- •women: pregnant or lactating (have to practice reliable method of contraception)
- •other severe diseases conflicting with a clinical study, contraindications for MRI
排除标准
- 未提供
研究组 & 干预措施
Placebo Arm
Patients receive placebo pills and Naproxene
干预措施: Tofacitinib 5 MG (Drug)
Tofactinib
Patients receive Tofacitinib and Naproxene
干预措施: Tofacitinib 5 MG (Drug)
结局指标
主要结局
Main trial endpoint
时间窗: 16 weeks
Proportion of subjects achieving disease remission defined as Ankylosing Spondylitis Disease Activity Score (ASDAS)CRP\<1.3 at week 16 from baseline
次要结局
- Change from baseline in the MRI SIJ SPARCC osteitis score at week 16(16 weeks)
研究者
Denis Poddubnyy
Prof. Dr. med.
Charite University, Berlin, Germany