EUCTR2017-003099-30-NL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or non-pregnant, non-lactating female patients 18 to 65 years of age at randomization
- •- Presence of unilateral rotator cuff tendinopathy with:
- •a. Symptoms present =6 weeks, but <12 months prior to randomization
- •b. Tendinopathy with no more than a 50% tear as established by ultrasound at screening (historic data acceptable if not older than 3 months) and MRI at baseline: Sein MRI tendinopathy scoring system grade I-III; with no tear or partial tear [maximum 50% tendon thickness (Bauer tendon thickness score maximum 2); AP length maximum 10 mm (Bauer tendon length score max 2)]. Maximum 50% of patients with partial tear
- •c. Pain in the affected shoulder (at rest or on movement) on at least 3 days out of 7 days in the past week prior to baseline and a score of =4 out of 10 on a VAS pain scale
- •d. Positive Painful Arc Test” on examination and/or nightly pain in the affected shoulder on at least 4 out of 7 days in the past week prior to baseline
- •- The rotator-cuff tendinopathy must have been refractory to standard treatment, including NSAIDs and physiotherapy
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 98
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA
- •- Previous shoulder surgery in affected shoulder
- •- History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline
- •- Symptomatic osteoarthritis of the shoulder (gleno-humeral, acromioclavicular) (in affected or contralateral shoulder confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline
- •- Neck conditions, including but not limited to cervical spine syndrome, which in the opinion of the investigator, may explain the patient’s symptoms
- •- Previous platelet rich plasma injections within the last 12 months prior to randomization
- •- Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents (e.g. Campath, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
- •- Previous exposure to any biologic immunomodulating agents, including but not limited to TNFalpha inhibitors (including, but not limited to adalimumab, infliximab), or biologics targeting IL-17 (including, but not limited to secukinumab, ixekizumab or brodalumab) or the IL-17 receptor within the last 12 months prior to baseline
- •- Any intraarticular/subacromial corticosteroid treatment within 8 weeks prior to randomization and more than 3 injections for the current tendinopathy. Oral, intramuscular or i.v. corticosteroid treatment within the last 12 months prior to randomization
- •Other protocol-defined exclusion criteria may apply.
研究者
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