← Back to Search

Tc 99m Tilmanocept Imaging for Rheumatoid Arthritis

Verified Trial

Phase 3

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

The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.

The subject is a candidate for initiation of, or change to, a new anti-TNFα bDMARD therapy.

Must not have

The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to the first imaging visit (Day 0).

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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

Who is the study for?

This trial is for adults diagnosed with moderate to severe active Rheumatoid Arthritis (RA) who are starting or changing anti-TNFα therapy. They must meet specific RA criteria, have been on stable doses of traditional DMARDs for at least 90 days, and not have had recent corticosteroid injections. People with hypersensitivity to TNF-inhibitors or adverse reactions to dextran, as well as those with certain hand surgeries, cannot participate.

What is being tested?

The study tests whether Tc 99m tilmanocept imaging can predict how well patients with RA will respond to new anti-TNFα therapy before they start treatment. It's a diagnostic tool that could help tailor individual patient care.

What are the potential side effects?

While the side effects of Tc 99m tilmanocept aren't detailed here, similar diagnostic agents may cause mild irritation at the injection site or allergic reactions in rare cases.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am about to start or change my anti-TNFα medication.

Select...

I have been diagnosed with rheumatoid arthritis.

Select...

I have been on the same DMARD dose for at least 30 days.

Select...

I have been on a stable dose of bDMARD or JAK inhibitor for more than 60 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had joint injections within the last 8 weeks.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 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

Sensitivity of Tilmanocept Uptake Value (TUV)

Specificity of Tilmanocept Uptake Value (TUV)

Secondary study objectives

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)

+10 more