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Subjects Free of Inflammatory Disease for Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Navidea Biopharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 days
Awards & highlights
No Placebo-Only Group

Summary

This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 39 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Normal Limits of TUVjoint in Healthy Subjects
Qualitative Evaluation of SPECT/CT for Tilmanocept Localization
Secondary study objectives
Normal Distribution of TUVjoint
Planar and SPECT/CT Comparison
Quantitative Evaluation of SPECT/CT

Side effects data

From 2019 Phase 2 trial • 24 Patients • NCT02509598
17%
Nausea
13%
Vomiting
9%
febrile neutropenia
4%
Anaemia
4%
hypokalaemia
4%
acute kidney injury
4%
pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tc99m Tilmanocept and Vital Blue Dye (Optional)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects Free of Inflammatory DiseaseExperimental Treatment1 Intervention
The first arm will be comprised of HCs who are deemed to be clinically free of inflammatory diseases, arthropathies, and/or arthroplasties and clinically free of joint pain for at least 28 days prior to the consent date.
Group II: Healthy Controls and RA Subjects on Stable TherapyExperimental Treatment1 Intervention
The second arm is comprised of \[1\] disease-free HCs and \[2\] clinically diagnosed RA subjects on stable treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tc99m tilmanocept
2015
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Navidea BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,728 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
680 Patients Enrolled for Rheumatoid Arthritis
Michael Blue, MDStudy DirectorNavidea Biopharmaceuticals
9 Previous Clinical Trials
742 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
680 Patients Enrolled for Rheumatoid Arthritis
~30 spots leftby Nov 2025
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