Rheumatoid Arthritis Clinical Trial
Official title:
Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging
NCT number | NCT02683421 |
Other study ID # | NAV3-23 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | December 2016 |
Verified date | November 2019 |
Source | Navidea Biopharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with active RA and concordance with clinical symptomology.
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Axis Clinical Trials | Los Angeles | California |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Navidea Biopharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints | The primary endpoint was to compare the cumulative total of anatomical zones of active RA (which were clinically defined by a swollen/tender classification during the DAS28 joint count assessment performed at baseline) with Tc 99m tilmanocept localization observed at 2-3 hours and at 4-6 hours after administration on Day 1. Tc 99m tilmanocept localization is defined by accumulation of radioactivity at an intensity greater than background, which was qualitatively determined by the central reader's visual assessment of the acquired images . | Swollen/tender joints assessment at baseline and Tc 99m tilmanocept localization at 2-3 hours and 4-6 hours after administration on Day 1 | |
Secondary | Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging | Tc 99m tilmanocept localization intensity on planar imaging was compared among dose/disease groups. Localization intensity was quantitatively analyzed by observing average voxel intensity in regions of interest, which were drawn over areas of increased uptake in the RA-affected joints. | 2-4 hours and 4-6 hours | |
Secondary | Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups | Tc 99m tilmanocept localization intensity on planar imaging relative to localization intensity in corresponding background regions was calculated (percent of background) for each region of interest and averaged for each dose/disease group. | 2-4 hours and 4-6 hours |
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