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Tc 99m tilmanocept for Rheumatoid Arthritis

Phase 2

Recruiting

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 through study completion, up to 45 days

Awards & highlights

Study Summary

This trial looked at whether a nuclear imaging agent could be used to detect a protein associated with RA, compared to the current standard of looking at synovial tissue under a microscope.

Who is the study for?

Adults diagnosed with Rheumatoid Arthritis (RA) who meet specific criteria, including being on stable doses of certain RA medications. They must not be pregnant or breastfeeding, have severe medical conditions, allergies to dextran, recent exposure to radiopharmaceuticals or investigational products, renal or hepatic insufficiency, and should not be undergoing radiation therapy or chemotherapy.Check my eligibility

What is being tested?

The trial is testing Tc 99m tilmanocept imaging's ability to detect CD206 in synovial tissue compared with standard IHC analysis in people with RA. It aims to see if this imaging can serve as a reliable indicator of disease activity within the joints.See study design

What are the potential side effects?

Potential side effects are not explicitly listed for Tc 99m tilmanocept; however, common side effects from similar diagnostic agents include irritation at injection site, allergic reactions, and possible interference with kidney function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 45 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 45 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 45 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

Correlation between joint-specific tilmanocept uptake and CD206 expression

Secondary outcome measures

Classification of synovial anatomic pathotype by IHC assessment

Correlation between CD206, CD68, and CD163 expression

Correlation between joint-specific tilmanocept uptake and CD68 and CD163 expression

Side effects data

From 2015 Phase 2 trial • 5 Patients • NCT02201420

20%

Leg Edema

20%

Nausea

20%

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Tc 99m Tilmanocept

Trial Design

1Treatment groups

Experimental Treatment

Group I: RA Subjects on Stable TherapyExperimental Treatment1 Intervention

RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tc 99m tilmanocept

2019

Completed Phase 2

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Navidea BiopharmaceuticalsLead Sponsor

20 Previous Clinical Trials

1,884 Total Patients Enrolled

4 Trials studying Rheumatoid Arthritis

792 Patients Enrolled for Rheumatoid Arthritis

Michael Blue, MDStudy DirectorNavidea Biopharmaceuticals

9 Previous Clinical Trials

853 Total Patients Enrolled

4 Trials studying Rheumatoid Arthritis

792 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.

How many individuals are being asked to take part in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is presently looking for 24 participants at 2 sites. The trial was first posted on 9/14/2021 and has been edited as recently as 9/13/2022."

Answered by AI

Can people currently sign up for this experiment?

"According to the public clinicaltrials.gov website, this study is still recruiting patients. The listing for this trial was first created on September 14th, 2021 and has been edited as recently as September 13th, 2022."

Answered by AI

Is Tc 99m tilmanocept a common medication used in clinical trials?

"Currently, there are 3 clinical trials involving Tc 99m tilmanocept. 0 of these ongoing studies have progressed to Phase 3 testing. While the majority of research is being conducted in London and California, 8 different states are running active trials."

Answered by AI

Tc 99m tilmanocept is most commonly associated with which medical procedures?

"Tc 99m tilmanocept is a diagnostic imaging agent used to treat patients with malignant melanoma of the skin or breast cancer."

Answered by AI

Are there any harmful effects to Tc 99m tilmanocept?

"Tc 99m tilmanocept's Phase 2 status means that, while there is some evidence suggesting it is safe, there is no data yet affirming its efficacy. Therefore, our team has given it a safety score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA

2021. "Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04078191.

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