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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

Study Summary

This study is evaluating whether a drug called tilmanocept can be used to measure the amount of a drug in the blood.

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

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

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
1,773 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
681 Patients Enrolled for Rheumatoid Arthritis
Michael Blue, MDStudy DirectorNavidea Biopharmaceuticals
9 Previous Clinical Trials
742 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
681 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
2021. "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04947137.
All > Rheumatoid Arthritis > Ra
~34 spots leftby Apr 2025
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