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Rheumatoid ArthritisPhase 3NCT05246280

Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA

A Phase 3 study testing TC99m-tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will confirm the ability of Tc 99m tilmanocept imaging to predict clinical response in individuals with RA who are beginning anti-TNFα therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
TC99m-tilmanocept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
13 sitesUnited States
Study dates
2 Mar 2022to 9 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
  • The subject is a candidate for initiation of, or change to, a new anti-TNFα bDMARD therapy.
  • The subject has RA as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score of ≥ 6/10).
  • The subject has moderate to severe RA as determined by a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]).
  • 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 janus kinase (JAK) inhibitor therapy must have been at a stable dose > 60 days prior to the first imaging visit (Day 0).
  • If the subject is receiving NSAIDS (nonsteroidal anti-inflammatory drug) or oral corticosteroids, the dose has been stable for > 28 days prior to the first imaging visit (Day 0). The corticosteroid dose must be ≤ 10 mg/day of prednisone or an equivalent steroid dose.

Who cannot join

  • The subject is pregnant or lactating.
  • The subject size or weight is not compatible with imaging per the investigator.
  • The subject is currently receiving radiation therapy or chemotherapy or has received radiation or chemotherapy within the past 5 years.
  • The subject has an active malignancy or a history of malignancy within the past 5 years.
  • The subject has had a finger, hand, and/or wrist amputation or hand or wrist joint arthroplasty.
  • The subject has renal insufficiency as demonstrated by a glomerular filtration rate of < 60 mL/min.
Show all 14Show fewer
  • The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 2 times the upper limit of normal.
  • The subject has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study participation.
  • The subject has a history of hypersensitivity reactions to TNF-inhibitors.
  • The subject has a known allergy to or has had an adverse reaction to dextran exposure.
  • The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration at the first imaging visit (Day 0).
  • The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to the first imaging visit (Day 0).
  • The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept at the first imaging visit (Day 0).
  • The subject has heart failure [New York Heart Association (NYHA) Class III-IV], a demyelinating disorder, or a chronic/latent infection [e.g., +Purified Protein Derivative (PPD) test, Human Immunodeficiency Virus (HIV), Hepatitis B].

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Highlands Advanced Rheumatology and Arthritis Center

    Avon Park, Florida, 33825

  • Attune Health Research

    Beverly Hills, California, 90211

  • Believe Clinical Trials

    Coral Springs, Florida, 33065

  • Arthritis and Osteoporosis Center of Coastal Bend

    Corpus Christi, Texas, 78415

  • Nouvelle Clinical Research

    Cutler Bay, Florida, 33189

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Vida Clinical Research

    Kissimmee, Florida, 34741

  • Physician Research Collaboration

    Lincoln, Nebraska, 68516

  • Life Clinical Trials

    Margate, Florida, 33063

  • D&H National Research Centers, Inc

    Miami, Florida, 33155

  • Advanced Clinical Research of Orlando

    Ocoee, Florida, 34761

  • University of California, San Francisco

    San Francisco, California, 94110

  • Essential Medical Research

    Tulsa, Oklahoma, 74137

Other trials in United States

About this study

Official title: Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

This study will confirm the ability of Tc 99m tilmanocept imaging to predict clinical response in individuals with RA who are beginning anti-TNFα therapy.

Read the detailed description

This is a prospective, open-label, multicenter study designed to evaluate the early predictive capacity of Tc 99m tilmanocept planar imaging for downstream clinical response(s) in individuals with moderate to severe RA who are candidates for change in anti-TNFα therapy. Temporal (Baseline to 5 week) differences in quantitative imaging will be correlated with longitudinal (Baseline to 12- and 24-week) assessments of clinical RA outcomes to evaluate the clinical utility of Tc 99m tilmanocept for the expedited evaluation of antirheumatic treatment efficacy when compared with longitudinal assessments in clinical practice.

Being tested
TC99m-tilmanocept
Keywords
RA, Tilmanocept
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TC99m-tilmanoceptDrug

    Also called tilmanocept, Lymphoseek

    Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.

Study groups in NCT05246280
Study groupRoleWhat they receive
Candidates for initiation of anti-TNFα bDMARD therapyExperimentalAll subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment.
Receives: Drug: TC99m-tilmanocept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Specificity of Tilmanocept Uptake Value (TUV)

    Specificity of the change in TUVglobal with bucketing from baseline to 5 weeks after a change in anti-TNFα therapy (ΔTUVglobal[5w] with bucketing) with respect to ACR50 at week 24 after the change in therapy.

    Measured: Up to 213 days

  2. Sensitivity of Tilmanocept Uptake Value (TUV)

    Sensitivity of the change in TUVglobal with bucketing from baseline to 5 weeks after change in anti-TNFα therapy (ΔTUVglobal[5w] with bucketing) with respect to ACR50 at week 24 after the change in therapy.

    Measured: Up to 213 days

Secondary outcomes (13)

  1. Negative Predictive Value (NPV) of TUV Baseline at Week 24

    NPV of TUV global obtained at baseline (TUVglobal[b]) with respect to ACR50 at week 24 after change in anti-TNFα therapy

    Measured: Up to 213 days

  2. Sensitivity and Specificity of ΔTUVglobal[5w] With Bucketing With Respect to ACR50 at Week 12

    Concordance of ΔTUVglobal[5w] with bucketing and ACR50 at week 12, evaluated using sensitivity and specificity.

    Measured: Up to 213 days

  3. NPV, and PPV, and OA of ΔTUVglobal[5w] With Bucketing With Respect to ACR50 at Weeks 12 and 24

    Concordance of ΔTUVglobal[5w] (with bucketing) and clinical criteria, including ACR Response Criteria, CDAI, DAS28, and HAQ-DI©. Concordance between ΔTUVglobal[5w] and the clinical criteria will be evaluated using NPV, PPV and overall accuracy.

    Measured: up to 213 days

  4. Negative Predictive Value (NPV) of TUV Baseline at Week 12

    Negative predictive value (NPV) of TUVglobal obtained at baseline (TUVglobal[b]) with respect to ACR50 at week 12

    Measured: up to 213 days

  5. 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

    TUVglobal[b] and response to new anti-TNFα bDMARD therapy defined by the change from baseline (CFB) of CDAI to 12 +/- 1 weeks and 24 +/- 1 weeks, by the CFB of DAS28 to 12 +/- 1 weeks and 24 +/- 1 weeks and by the CFB in each of the ACR Response Criteria components at 12 +/- 1 weeks and at 24 +/- 1 weeks.

    Measured: Up to 213 days

  6. Concordance of TUV Baseline to Week 5 and Change in Clinical Disease Activity Index (CDAI)

    ΔTUVglobal[5w] and response to new anti-TNFα bDMARD therapy defined by the CFB of CDAI to 12 +/- 1 weeks and 24 +/- 1 weeks.

    Measured: Up to 213 days

  7. 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

    Concordance of ΔTUVglobal[5w] (without bucketing) and clinical criteria, including ACR Response Criteria, CDAI, DAS28, and HAQ-DI©. Concordance between ΔTUVglobal[5w] and the clinical criteria will be evaluated using NPV, PPV, sensitivity, specificity, and overall accuracy.

    Measured: Up to 213 days

  8. 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 ΔTUVglobal[12w] and change in clinical criteria, including ACR Response Criteria, CDAI, DAS28, and HAQ-DI©. Concordance between ΔTUVglobal[12w] and the clinical criteria will be evaluated using NPV, PPV, sensitivity, specificity, and overall accuracy.

    Measured: Up to 213 days

  9. Correlation of TUV Baseline to Week 5 and ACR Response Criteria Components

    Correlation of ΔTUVglobal[5w] and response to new anti-TNFα bDMARD therapy from baseline to 24 +/- 1 weeks defined by the changes from baseline in each of the ACR Response Criteria components, including:

    • Tender joint count (TJC)
    • Swollen joint count (SJC)
    • Patient assessment of global disease activity
    • Rheumatologist assessment of global disease activity
    • Patient assessment of pain
    • Patient assessment of physical function
    • Acute-phase reactant value

    Measured: Up to 213 days

  10. Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs

    Incidence of AEs related to Tc 99m tilmanocept.

    Measured: Up to 213 days

  11. Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in Clinical Laboratory Tests

    Number of participants with changes over time in clinical laboratory tests (hematology, serum chemistry, urinalysis, and RA panel).

    Measured: Up to 213 days

  12. Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in ECG Parameters

    Number of participants with changes over time in ECG parameters (PRS Interval, QRS Duration, QT Interval, and QTc Interval).

    Measured: Up to 213 days

  13. Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in Vital Signs

    Number of participants with changes over time in vital signs (blood pressure, heart rate, respiratory rate, and temperature).

    Measured: Up to 213 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start2 Mar 2022
  3. Primary completion9 Jul 2024
  4. Study completion9 Jul 2024

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05246280
Sponsor's protocol ID
NAV3-33
Status last verified
Jan 2025
First submitted
16 Dec 2021
Last updated
23 Jan 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TC99m-tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specificity of Tilmanocept Uptake Value (TUV) (time frame: Up to 213 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05246280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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