Rheumatoid ArthritisPhase 2NCT04078191
Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA
A Phase 2 study testing Tc 99m tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 4 sites in 2 countries.
Trial summary
This study is a comparison of quantitative Tc 99m tilmanocept imaging with IHC analysis of CD206 expression in synovial tissue of RA subjects. 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?
- Tc 99m tilmanocept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Sep 2021to 9 Jul 2024
- Phase
- Phase 2
- 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) 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.
- The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
- 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 at or before screening).
- The subject has a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the C-reactive protein [CRP] 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).
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- If the subject is receiving biologic disease-modifying antirheumatic drug (bDMARD) or janus kinase (JAK) inhibitor therapy, they have been at a stable dose > 180 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 at a stable dose for ≥ 28 days prior to imaging. The corticosteroid dose should be ≤ 10 mg/day of prednisone or an equivalent steroid dose.
- The subject has a hand or wrist joint with a minimum ultrasound gray-scale synovitis score of 2 (range 0 to 3).
Who cannot join
- The subject is pregnant or lactating.
- The subject size or weight is not compatible with imaging per the investigator.
- The subject has had or is currently receiving radiation therapy or chemotherapy.
- The subject has renal insufficiency as demonstrated by a glomerular filtration rate of < 60 mL/min.
- The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 3 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.
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- 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 (Day 0).
- The subject has received intra-articular corticosteroids ≤ 8 weeks prior to imaging (Day 0).
- The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept (Day 0).
- The subject has an intolerance to anesthetic and antiseptic agents indicated for the synovial biopsy procedure.
- The subject is currently receiving anticoagulants (oral anti-platelet agents are permitted) or has a condition that is contraindicated with ultrasound-guided synovial biopsy e.g., needle phobia.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Attune Health
Beverly Hills, California, 90210
Northwestern University
Chicago, Illinois, 60208
United Kingdom2 sites
Barts Hospital
London, England
Royal Free Hospital
London, England
About this study
Official title: A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)
This study is a comparison of quantitative Tc 99m tilmanocept imaging with IHC analysis of CD206 expression in synovial tissue of RA subjects.
Read the detailed description
This is a Manocept Platform phase 2b, open-label, multi-center, multinational, non-randomized, single-dose study designed to assess the relationship between quantitative Tc 99m tilmanocept planar imaging and synovial histopathology in subjects clinically diagnosed with RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tc 99m tilmanocept
- Keywords
- tilmanocept, RA imaging, synovial biopsy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc 99m tilmanoceptDrug
Also called Lymphoseek
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
| Study group | Role | What they receive |
|---|---|---|
| RA Subjects on Stable Therapy | Experimental | RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Receives: Drug: Tc 99m tilmanocept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Joint-specific Tilmanocept Uptake and CD206 Expression
The correlation between joint-specific tilmanocept uptake value (TUVjoint) and the number and area fraction of CD206 expression as determined by IHC assessment.
Measured: Through study completion, up to 45 days
Secondary outcomes (2)
Correlation Between Joint-specific Tilmanocept Uptake and CD68 and CD163 Expression
The correlation between TUVjoint and the number and area fraction of CD68 and CD163 determined by IHC assessments.
Measured: Through study completion, up to 45 days
Classification of Synovial Anatomic Pathotype by IHC Assessment
Classification of synovial anatomic pathology into
- Lympho-myeloid
- Diffuse myeloid
- Pauci-immune fibroid types as a function of CD68, CD163, CD206, CD3, CD20, CD55, and TE7 expression determined by IHC assessments using a polytomous logistic regression model.
Measured: Through study completion, up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start14 Sep 2021
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Why it stopped: Sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navidea Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Blue, MD, Study director, Navidea Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078191
- Sponsor's protocol ID
- NAV3-32
- Other IDs
- 2018-003418-41, 2018
- Status last verified
- Jul 2024
- First submitted
- 21 Aug 2019
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT04078191
- Acronym / sponsor ID
- NAV3-32
- Conditions
- Rheumatoid Arthritis
- Keywords
- tilmanocept, RA imaging, synovial biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Navidea BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comparison of quantitative Tc 99m tilmanocept imaging with IHC analysis of CD206 expression in synovial tissue of RA subjects.
Detailed description
This is a Manocept Platform phase 2b, open-label, multi-center, multinational, non-randomized, single-dose study designed to assess the relationship between quantitative Tc 99m tilmanocept planar imaging and synovial histopathology in subjects clinically diagnosed with RA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA Subjects on Stable Therapy | Experimental | Drug: Tc 99m tilmanoceptRA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
- 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 at or before screening).
- The subject has a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the C-reactive protein [CRP] test and visual analog scale [VAS]).
Key exclusion criteria (12 listed)
- The subject is pregnant or lactating.
- The subject size or weight is not compatible with imaging per the investigator.
- The subject has had or is currently receiving radiation therapy or chemotherapy.
- The subject has renal insufficiency as demonstrated by a glomerular filtration rate of < 60 mL/min.
- The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 3 times the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc 99m tilmanoceptAlso: LymphoseekTilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. | Drug | RA Subjects on Stable Therapy |
Primary outcome
Correlation Between Joint-specific Tilmanocept Uptake and CD206 Expression
Time frame: Through study completion, up to 45 days
The correlation between joint-specific tilmanocept uptake value (TUVjoint) and the number and area fraction of CD206 expression as determined by IHC assessment.
2 secondary outcomes
Correlation Between Joint-specific Tilmanocept Uptake and CD68 and CD163 Expression
Time frame: Through study completion, up to 45 days
Classification of Synovial Anatomic Pathotype by IHC Assessment
Time frame: Through study completion, up to 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Blue, MD study director
Navidea Biopharmaceuticals
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc 99m tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 4 sites in 2 countries.
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 9 inclusion and 12 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 8 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 4 sites in United States, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 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?
Correlation Between Joint-specific Tilmanocept Uptake and CD206 Expression (time frame: Through study completion, up to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2025.