Healthy Volunteers: 50 mcg tilmanocept with 2 millicuries (mCi) Tc 99m

Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m

RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m

RA group:200 mcg tilmanocept with 2 mCi Tc 99m

Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m
Tilmanocept

Control Subjects: 50 mcg/20 mCi Dose

Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m
Tilmanocept

Control Subjects: 200 mcg/2 mCi Dose

RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m
Tilmanocept

RA Subjects: 50 mcg/2 mCi Dose

RA group:200 mcg tilmanocept with 2 mCi Tc 99m
Tilmanocept

RA Subjects: 200 mcg/2 mCi Dose

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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 .

Control Subjects: 50 mcg/2 mCi Dose

Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints

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.

Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging

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.

Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups

Healthy Volunteers: 50 mcg tilmanocept with 2 millicuries (mCi) Tc 99m
Tilmanocept

Controls Subjects: 200 mcg/2mCi Dose

Rheumatoid arthritis (RA) Group: 50 mcg tilmanocept with 2 mCi Tc 99m
Tilmanocept

Overall Study

Bonnie C. Abbruzzese, MS, RD

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Rheumatoid Arthritis

Tilmanocept

Axis Clinical Trials

University of California, San Francisco

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

Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging

Navidea Biopharmaceuticals

Receive treatment with hydroxychloroquine

Hashimoto Thyroiditis

Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months

Hydroxychloroquine

Department of Internal Medicine, National Taiwan University Hospital

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Check anti-TPO antibody 6 months after medical treatment as inflammatory marker

Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status

Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid

Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment

Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment

National Taiwan University Hospital

Systemic Lupus Erythematosus

atorvastatin 40mg, given orally daily for 3 months.

rheumatic diseases/protease

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

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors

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