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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02683421 |
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Date of registration:
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22/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging
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Scientific title:
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Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02683421 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Blue, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Navidea Biopharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Tilmanocept
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Primary Outcome(s)
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Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints
[Time Frame: Swollen/tender joints assessment at baseline and Tc 99m tilmanocept localization at 2-3 hours and 4-6 hours after administration on Day 1]
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Secondary Outcome(s)
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Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups
[Time Frame: 2-4 hours and 4-6 hours]
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Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging
[Time Frame: 2-4 hours and 4-6 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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