Efficacy of Tofacitinib in Reduction of Inflammation Detected on MRI in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement - a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- MRI Berlin Score
研究概览
简要总结
To evaluate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and spine on magnetic resonance imaging (MRI) in patients with active Psoriatic Arthritis (PsA) with axial Involvement (BASDAI [Bath Ankylosing Spondylitis Disease Activity Index] ≥ 4 and total backpain ≥ 4 despite treatment with NSAIDs plus evidence of active inflammation in the sacroiliac joints or spine on MRI).
详细描述
This study is a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and in the spine on MRI in patients with active axial PsA.
Eligible patients (n=80) will be randomized 1:1 to receive either Tofacitinib 5mg orally twice daily or placebo for a 12-week period. After week 12, all patients will receive Tofacitinib 5mg orally twice daily for another 12 weeks. The study duration will include a 6-week screening period, a 24-week treatment period and a safety follow-up period of 4 weeks. Patients will be closely monitored throughout the study on a total of 11 visits. Safety data will be collected in the form of adverse events, vital parameters, physical examinations, and laboratory parameters throughout the study.
The baseline MRI of the whole spine and sacroiliac (SI) joints will be performed within the 6-week screening period to confirm the presence of active inflammation (bone marrow edema) compatible with Spondyloarthritis (will be assessed by a central reader), at week 12 to evaluate the primary study endpoint, and at week 24 to evaluate the secondary endpoint.
The primary study endpoint will be an improvement of the total Berlin MRI score for sacroiliac joints and spine at week 12 as compared to baseline.
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
- •Psoriatic Arthritis fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria
- •chronic back pain > 3 months
- •BASDAI value ≥ 4 and backpain ≥ 4 / 10 VAS
- •presence of active inflammation in Screening MRI of sacroiliac joints and / or spine (central reading)
- •history of inadequate response to ≥ 2 NSAIDs or intolerance / contraindications
排除标准
- •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
研究组 & 干预措施
Tofacitinib
5 mg oral BID
干预措施: Tofacitinib 5 MG Oral Tablet [Xeljanz] (Drug)
Placebo
matching Placebo BID
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
MRI Berlin Score
时间窗: Week 12 vs Baseline
Improvement of the Berlin MRI score for sacroiliac joints and spine. Scoring includes spinal inflammation (Lucas C et al, J Rheumatol 2007): 23 vertebral units with semiquantitative range of inflammation between 0 to 3 (min. score = 0, max. score = 69, the higher the worse). Additionally, inflammation of the sacroiliac joints is scored (Hermann KG, Rheumatologe 2004; scoring each quadrant between 0 and 4, max. score 16, the higher, the worse).
次要结局
- Responses in ASDAS(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in Physician Global Score(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in ASAS Health Index(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in BASDAI(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in HAQ-DI(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in PASI(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in MASES(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in BASFI(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in BASMI(lin)(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- The Assessment of Spondyloarthritis International Society (ASAS) response criteria(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- MRI Berlin Score(Week 24 vs Baseline, Week 24 vs Week 12)
- Response in CRP(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in Patient Global Score(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Responses in DAPSA(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
- Response in ESR(Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12)
研究者
Denis Poddubnyy
Prof. Dr. Denis Poddubnyy
Charite University, Berlin, Germany