TC99m-tilmanocept for Rheumatoid Arthritis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Rheumatoid Arthritis+2 More
TC99m-tilmanocept - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a certain imaging can predict how well a person with RA will respond to anti-TNFα therapy.

Eligible Conditions
  • Rheumatoid Arthritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Rheumatoid Arthritis

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Up to 213 days

Up to 213 days
Concordance of TUV Baseline and Change in Clinical Disease Activity Index (CDAI), 28-joint count Disease Activity Score (DAS28), and American College of Rheumatology (ACR) Response Criteria
Concordance of TUV Baseline to Week 12 and Clinical Disease Activity Index (CDAI),28-joint count Disease Activity Score (DAS28), and American College of Rheumatology (ACR) Response Criteria
Concordance of TUV Baseline to Week 5 and Change in Clinical Disease Activity Index (CDAI)
Concordance of TUV Baseline to Week 5 and Clinical Disease Activity Index (CDAI),28-joint count Disease Activity Score (DAS28), and American College of Rheumatology (ACR) Response Criteria
Correlation of TUV Baseline to Week 5 and ACR Response Criteria Components
Negative predictive value (NPV) of TUV Baseline at Week 24
Safety of IV-administered Tilmanocept Radiolabled with Tc 99m Assessed by AEs
Safety of IV-administered Tilmanocept Radiolabled with Tc 99m Assessed by Number of Participants with Changes Over Time in Clinical Laboratory Tests
Safety of IV-administered Tilmanocept Radiolabled with Tc 99m Assessed by Number of Participants with Changes Over Time in ECG Parameters
Safety of IV-administered Tilmanocept Radiolabled with Tc 99m Assessed by Number of Participants with Changes Over Time in Vital Signs
Sensitivity and specificity of ΔTUVglobal[5w] with bucketing with respect to ACR50 at Week 12
Sensitivity of Tilmanocept Uptake Value (TUV)
Specificity of Tilmanocept Uptake Value (TUV)
up to 213 days
NPV, and PPV, and OA of ΔTUVglobal[5w] with bucketing with respect to ACR50 at Weeks 12 and 24
Negative predictive value (NPV) of TUV Baseline at Week 12

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Rheumatoid Arthritis

Trial Design

1 Treatment Group

Candidates for initiation of anti-TNFα bDMARD therapy
1 of 1
Experimental Treatment

523 Total Participants · 1 Treatment Group

Primary Treatment: TC99m-tilmanocept · No Placebo Group · Phase 3

Candidates for initiation of anti-TNFα bDMARD therapy
Drug
Experimental Group · 1 Intervention: TC99m-tilmanocept · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TC99m-tilmanocept
2019
Completed Phase 2
~100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 213 days

Who is running the clinical trial?

Navidea BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,364 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
272 Patients Enrolled for Rheumatoid Arthritis
Michael Blue, MDStudy DirectorNavidea Biopharmaceuticals
9 Previous Clinical Trials
333 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
272 Patients Enrolled for Rheumatoid Arthritis

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects receiving traditional DMARDs must have been on therapy for ≥ 90 days and at a stable dose for ≥ 30 days prior to the first imaging visit (Day 0).
Subjects receiving bDMARD or JAK inhibitor therapy must have been at a stable dose > 60 days prior to the first imaging visit (Day 0).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Nebraska100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%