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TERMINATEDPHASE3

Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA

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)

NCT05246280•Navidea Biopharmaceuticals

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
•2. The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
•3. The subject is a candidate for initiation of, or change to, a new anti-TNFα bDMARD therapy.
•4. 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).
•5. 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 \[VAS\]).
•6. 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).
•7. 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).
•8. 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 Criteria

•1. The subject is pregnant or lactating.
•2. The subject size or weight is not compatible with imaging per the investigator.
•3. The subject is currently receiving radiation therapy or chemotherapy or has received radiation or chemotherapy within the past 5 years.
•4. The subject has an active malignancy or a history of malignancy within the past 5 years.
•5. The subject has had a finger, hand, and/or wrist amputation or hand or wrist joint arthroplasty.
•6. The subject has renal insufficiency as demonstrated by a glomerular filtration rate of \< 60 mL/min.
•7. 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.
•8. 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.
•9. The subject has a history of hypersensitivity reactions to TNF-inhibitors.
•10. The subject has a known allergy to or has had an adverse reaction to dextran exposure.
+4 more criteria

Locations (13)

Attune Health Research

Beverly Hills, California, United States

University of California, San Francisco

San Francisco, California, United States

Highlands Advanced Rheumatology and Arthritis Center

Avon Park, Florida, United States

Believe Clinical Trials

Coral Springs, Florida, United States

Nouvelle Clinical Research

Cutler Bay, Florida, United States

Vida Clinical Research

Kissimmee, Florida, United States

Life Clinical Trials

Margate, Florida, United States

D&H National Research Centers, Inc

Miami, Florida, United States

Advanced Clinical Research of Orlando

Ocoee, Florida, United States

Physician Research Collaboration

Lincoln, Nebraska, United States

Key Dates

Start Date

March 2, 2022

Primary Completion Date

July 9, 2024

Completion Date

July 9, 2024

Last Updated

January 23, 2025

Enrollment

169

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

TC99m-tilmanocept

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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