← Back to Search

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
The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) or equivalent authorization before the initiation of any study-related procedures.
Women and men of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study.
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.

Eligible Conditions
  • Rheumatoid Arthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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%
Nausea
20%
Leg Edema
20%
Fatigue
100%
80%
60%
40%
20%
0%
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

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
~7 spots leftby Mar 2025