Status:
TERMINATED
Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA
Lead Sponsor:
Navidea Biopharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 mod...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 \[e.g., +Purified Protein Derivative (PPD) test, Human Immunodeficiency Virus (HIV), Hepatitis B\].
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT05246280
Start Date
March 2 2022
End Date
July 9 2024
Last Update
January 23 2025
Active Locations (13)
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1
Attune Health Research
Beverly Hills, California, United States, 90211
2
University of California, San Francisco
San Francisco, California, United States, 94110
3
Highlands Advanced Rheumatology and Arthritis Center
Avon Park, Florida, United States, 33825
4
Believe Clinical Trials
Coral Springs, Florida, United States, 33065