Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- 99mTc-rhAnnexin V-128 Uptake
研究概览
简要总结
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions.
Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.
详细描述
The study was prematurely terminated by the sponsor after the first 5 patients completed the PoC phase based on strategic considerations.
Novartis acquired Advanced Accelerator Applications SA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •For the first 5 patients enrolled in the POC part:
- •Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASA criteria with active symptoms including back, hip or buttock pain prior to:
- •A change in NSAID therapy or
- •A change in non-biologic DMARD or
- •A start of non-biologic DMARD.
- •For the next 15 patients enrolled in the Phase II part:
- •Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASAS criteria with active symptoms including back, hip or buttock pain prior to:
- •A change in NSAIDs therapy
- •A change in non-biologic DMARD
- •A start of non-biologic DMARD
- •A start of biologic DMARD
- •For all patients:
- •Age over 18 years old.
- •Signed Informed Consent Form
排除标准
- •Pregnancy or lactation
- •Liver impairment (ALT, AST or Bilirubin > 2 ULN) at screening visit or baseline
- •Kidney impairment (serum creatinine > 1.5 mg/dL)
- •History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
- •Known hypersensitivity to the investigational drug or any of its components
- •Contraindication(s) to the MRI procedure (claustrophobia, prosthetic valve, pacemaker, inability to lie still in a supine position)
- •Participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
研究组 & 干预措施
rhAnnexin V-128
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
干预措施: rhAnnexin V-128 (Drug)
结局指标
主要结局
99mTc-rhAnnexin V-128 Uptake
时间窗: 60 minutes and 120 minutes post investigational product adminstration
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. Uptake compared with background (e.g. physiological liver uptake) were assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but \< to background uptake; 2, moderate or = to background uptake; 3, intense or \> to background uptake). Only descriptive analysis performed.
99mTc-rhAnnexin V-128 Uptake Adjudication
时间窗: 60 minutes and 120 minutes post investigational product adminstration
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. In case of discrepancies between the different readers, an adjudication process based on consensus was put in place in order to obtain one final outcome for each area. Adjudication results were categorized as Positive or Negative. Only descriptive analysis performed.
次要结局
未报告次要终点