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

Stopped early · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT05246280

Run by

Navidea Biopharmaceuticals

People needed

169

Starts

2022-03-02

Expected to finish

2024-07-09

Last updated by the study team

2025-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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].

Where it is running

• 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
• Essential Medical Research — Tulsa, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Arthritis and Osteoporosis Center of Coastal Bend — Corpus Christi, Texas, United States

Full record on ClinicalTrials.gov

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