Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with active RA and concordance with clinical symptomology.

Key facts

Study ID

NCT02683421

Run by

Navidea Biopharmaceuticals

People needed

18

Starts

2016-07-01

Expected to finish

2016-12-01

Last updated by the study team

2019-11-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject has provided written informed consent with HIPPA authorization before the initiation of any study-related procedures.
• CONTROLS:
• The subject is between 21-45 years of age at the time of consent.
• The subject has not experienced joint pain for at least 4 weeks prior to the consent date and is deemed to be clinically free of any inflammatory disease(s).
• ACTIVE RHEUMATOID ARTHRITIS
• The subject is at least 21 years of age at the time of consent.
• The subject has moderate to severe RA, based on either the 1987American College of Rheumatology (ACR) score of ≥ 4/7 or the 2010 ACR/EULAR score of ≥ 6/10.
• The subject has a DAS28 of >4.4 (using the ESR).
• If the subject is on methotrexate, they have been at a stable dose for > 4 weeks prior to the screening visit.
• If the subject is on biologic therapy, they have been at a stable dose > 8 weeks prior to the screening visit.
• If the subject is on non-steroidal anti-inflammatories (NASIDS) or oral corticosteroids, it is ≤ 10mgmg/day or equivalent, and has been at a stable dose for > 4 weeks prior to the screening visit.

You may not qualify if…

• The subject is pregnant or lactating.
• BMI >32.0.
• The subject has had or is currently receiving chemotherapy for a non-inflammatory related condition or radiation therapy.
• Chronic or persistent infection or has any condition that would, in the opinion of the examining physician, preclude their participation.
• The subject has a known allergy to or has had a reaction to dextran exposure.
• The subject has received an investigational product within 30 days prior to he Tc99m tilmanocept administration.
• The subject has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical prior to the administration of Tc 99m tilmanocept.

Where it is running

• Axis Clinical Trials — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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