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Tc 99m Tilmanocept Imaging for Rheumatoid Arthritis
Verified Trial
Phase 3
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) 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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity of Tilmanocept Uptake Value (TUV)
Specificity of Tilmanocept Uptake Value (TUV)
Secondary outcome measures
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Candidates for initiation of anti-TNFα bDMARD therapyExperimental Treatment1 Intervention
All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment.
Find a Location
Who is running the clinical trial?
Navidea BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,385 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
293 Patients Enrolled for Rheumatoid Arthritis
Michael Blue, MDStudy DirectorNavidea Biopharmaceuticals
9 Previous Clinical Trials
354 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
293 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on the same DMARD dose for at least 30 days.I have been diagnosed with rheumatoid arthritis.You have had an allergic reaction or a bad response to dextran before.I have been on a stable dose of bDMARD or JAK inhibitor for more than 60 days.I have had surgery to remove a finger, hand, or wrist or had joint replacement in these areas.I have had joint injections within the last 8 weeks.I am about to start or change my anti-TNFα medication.You have had allergic reactions in the past to medications called TNF-inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Candidates for initiation of anti-TNFα bDMARD therapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are involved in this experiment?
"A total of 523 patients are necessary to enroll in this clinical trial. If you fulfill the required inclusion criteria, you may be able to participate at sites such as Physician Research Collaboration in Lincoln, Nebraska and Vida Clinical Research in Kissimmee, Pennsylvania."
Answered by AI
Has the FDA cleared TC99m-tilmanocept for use?
"There is some evidence of efficacy and numerous reports of safety, so our team at Power has given TC99m-tilmanocept a score of 3."
Answered by AI
Are there any unfilled spots in this trial that I could sign up for?
"The clinical trial listed on clinicaltrials.gov is actively recruiting participants. The study was first posted on March 2, 2022 and last updated on September 1, 2022."
Answered by AI
Where can patients participate in this research?
"There are 12 sites currently enrolling patients for this study. If you are interested in participating, consider enrolling at the location closest to you to reduce travel costs and time."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Altoona Center for Clinical Research
Nouvelle Clinical Research
Einstein Healthcare Network
Other
Why did patients apply to this trial?
Because I Have Arthritis. I have been struggling with rheumatoid arthritis for years and anything helps.
PatientReceived no prior treatments
I have rheumatid arthritis for at least 10 years now I’d like to try to study. Please give me a call at 484-908-1240 Sandi Max.
PatientReceived 2+ prior treatments
I have tried several drugs. I am taking an infusion now for my RA. I keep holding out for something that will help my pain and my breakthrough pain.
PatientReceived 2+ prior treatments
They want to start injections but I’d like to see if something else will work that will further advance the study to benefit others and well as myself.
PatientReceived 2+ prior treatments
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