NCT05246280终止3 期
Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Navidea Biopharmaceuticals13 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2022年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 169
- 试验地点
- 13
- 主要终点
- Sensitivity of Tilmanocept Uptake Value (TUV)
研究概览
简要总结
This study will confirm the ability of Tc 99m tilmanocept imaging to predict clinical response in individuals with RA who are beginning anti-TNFα therapy.
详细描述
This is a prospective, open-label, multicenter study designed to evaluate the early predictive capacity of Tc 99m tilmanocept planar imaging for downstream clinical response(s) in individuals with moderate to severe RA who are candidates for change in anti-TNFα therapy. Temporal (Baseline to 5 week) differences in quantitative imaging will be correlated with longitudinal (Baseline to 12- and 24-week) assessments of clinical RA outcomes to evaluate the clinical utility of Tc 99m tilmanocept for the expedited evaluation of antirheumatic treatment efficacy when compared with longitudinal assessments in clinical practice.
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
- •The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
- •The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
- •The subject is a candidate for initiation of, or change to, a new anti-TNFα bDMARD therapy.
- •The subject has RA as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score of ≥ 6/10).
- •The subject has moderate to severe RA as determined by a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]).
- •Subjects receiving traditional DMARDs must have been on therapy for ≥ 90 days and at a stable dose for ≥ 30 days prior to the first imaging visit (Day 0).
- •Subjects receiving bDMARD or janus kinase (JAK) inhibitor therapy must have been at a stable dose > 60 days prior to the first imaging visit (Day 0).
- •If the subject is receiving NSAIDS (nonsteroidal anti-inflammatory drug) or oral corticosteroids, the dose has been stable for > 28 days prior to the first imaging visit (Day 0). The corticosteroid dose must be ≤ 10 mg/day of prednisone or an equivalent steroid dose.
排除标准
- •The subject is pregnant or lactating.
- •The subject size or weight is not compatible with imaging per the investigator.
- •The subject is currently receiving radiation therapy or chemotherapy or has received radiation or chemotherapy within the past 5 years.
- •The subject has an active malignancy or a history of malignancy within the past 5 years.
- •The subject has had a finger, hand, and/or wrist amputation or hand or wrist joint arthroplasty.
- •The subject has renal insufficiency as demonstrated by a glomerular filtration rate of < 60 mL/min.
- •The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 2 times the upper limit of normal.
- •The subject has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study participation.
- •The subject has a history of hypersensitivity reactions to TNF-inhibitors.
- •The subject has a known allergy to or has had an adverse reaction to dextran exposure.
- •The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration at the first imaging visit (Day 0).
- •The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to the first imaging visit (Day 0).
- •The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept at the first imaging visit (Day 0).
- •The subject has heart failure [New York Heart Association (NYHA) Class III-IV], a demyelinating disorder, or a chronic/latent infection [e.g., +Purified Protein Derivative (PPD) test, Human Immunodeficiency Virus (HIV), Hepatitis B].
研究组 & 干预措施
Candidates for initiation of anti-TNFα bDMARD therapy
Experimental
All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment.
干预措施: TC99m-tilmanocept (Drug)
结局指标
主要结局
Sensitivity of Tilmanocept Uptake Value (TUV)
时间窗: Up to 213 days
Sensitivity of the change in TUVglobal with bucketing from baseline to 5 weeks after change in anti-TNFα therapy (ΔTUVglobal\[5w\] with bucketing) with respect to ACR50 at week 24 after the change in therapy.
Specificity of Tilmanocept Uptake Value (TUV)
时间窗: Up to 213 days
Specificity of the change in TUVglobal with bucketing from baseline to 5 weeks after a change in anti-TNFα therapy (ΔTUVglobal\[5w\] with bucketing) with respect to ACR50 at week 24 after the change in therapy.
次要结局
- Negative Predictive Value (NPV) of TUV Baseline at Week 24(Up to 213 days)
- Sensitivity and Specificity of ΔTUVglobal[5w] With Bucketing With Respect to ACR50 at Week 12(Up to 213 days)
- NPV, and PPV, and OA of ΔTUVglobal[5w] With Bucketing With Respect to ACR50 at Weeks 12 and 24(up to 213 days)
- Negative Predictive Value (NPV) of TUV Baseline at Week 12(up to 213 days)
- Concordance of TUV Baseline and Change in Clinical Disease Activity Index (CDAI), 28-joint Count Disease Activity Score (DAS28), and American College of Rheumatology (ACR) Response Criteria(Up to 213 days)
- Concordance of TUV Baseline to Week 5 and Change in Clinical Disease Activity Index (CDAI)(Up to 213 days)
- Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs(Up to 213 days)
- Concordance of TUV Baseline to Week 5 and Clinical Disease Activity Index (CDAI),28-joint Count Disease Activity Score (DAS28), and American College of Rheumatology (ACR) Response Criteria(Up to 213 days)
- Concordance of TUV Baseline to Week 12 and Clinical Disease Activity Index (CDAI),28-joint Count Disease Activity Score (DAS28), and American College of Rheumatology (ACR) Response Criteria(Up to 213 days)
- Correlation of TUV Baseline to Week 5 and ACR Response Criteria Components(Up to 213 days)
- Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in Clinical Laboratory Tests(Up to 213 days)
- Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in ECG Parameters(Up to 213 days)
- Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in Vital Signs(Up to 213 days)
研究者
研究点 (13)
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