Rheumatoid ArthritisPhase 2NCT04947137
Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
A Phase 2 study testing Tc99m tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 7 sites in United States.
Trial summary
This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 134 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 May 2021to 21 Jan 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALL SUBJECTS
- 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 has agreed to not engage in any diet, lifestyle, or medication changes until study completion.
- HEALTHY CONTROL SUBJECTS
- The subject is 30 years of age or greater at the time of consent.
- The subject is deemed to be clinically free of any inflammatory disease(s), autoimmune disease(s), or arthropathies and has not experienced joint pain for at least 28 days prior to the consent date.
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- The subject is not currently on anti-inflammatory drugs (including non-steroidal anti-inflammatory drugs [NSAIDs]) and has not taken any anti-inflammatories for at least 28 days prior to the consent date.
- For all ongoing concomitant medications, the subject has maintained a stable dose for at least 28 days prior to the consent date.
- CLINICALLY DIAGNOSED ACTIVE RA SUBJECTS
- 3. The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
- 4. The subject has moderate to severe RA as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score of ≥ 6/10).
- 5. The subject has a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]).
- 6. Subjects receiving traditional DMARDs must have been on therapy for ≥ 90 days and at a stable dose for ≥ 30 days prior to the imaging visit (Day 0). 7. If the subject is receiving bDMARD or janus kinase (JAK) inhibitor therapy, they have been at a stable dose > 60 days prior to the imaging visit (Day 0). 8. If the subject is receiving NSAIDs or oral corticosteroids, the dose has been stable for ≥ 28 days prior to the 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 therapy or chemotherapy in the past six months.
- 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.
- 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.
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- 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 or compromise the safety of the subject or the quality of the data.
- The subject has any unstable medical illnesses, including hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- 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 Tc 99m tilmanocept administration (Day 0).
- The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to Tc 99m tilmanocept administration (Day 0).
- The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to Tc 99m tilmanocept administration (Day 0).
- Healthy Controls only: The subject has a positive rheumatoid factor and an elevated ESR or CRP.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Kettering Medical Center
Kettering, Ohio, 45429
San Marcus Research Clinic
Miami Lakes, Florida, 33014
Innovation Medical Research Center
Palmetto Bay, Florida, 33157
Sun Research Institute
San Antonio, Texas, 78215
Essential Medical Research
Tulsa, Oklahoma, 74137
Tranquility Research
Webster, Texas, 77598
About this study
This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.
Read the detailed description
This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA.
This study is stratified into 2 arms. Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tc99m tilmanocept
- Keywords
- RA, Healthy control, 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 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 |
|---|---|---|
| Subjects Free of Inflammatory Disease | Experimental | The first arm will be comprised of HCs who are deemed to be clinically free of inflammatory diseases, arthropathies, and/or arthroplasties and clinically free of joint pain for at least 28 days prior to the consent date. Receives: Drug: Tc99m tilmanocept |
| Healthy Controls and RA Subjects on Stable Therapy | Experimental | The second arm is comprised of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment. Receives: Drug: Tc99m tilmanocept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Limits of TUVjoint in Healthy Subjects
The normal limits of TUVjoint (on a per joint basis) in HC subjects, which are defined as the 5 and 95 percentiles of TUVjoint of bilateral joints (i.e., bilateral wrists, metacarpophalangeal joint [MCPs], proximal interphalangeal [PIPs]).
Measured: Up to 39 days
Qualitative Evaluation of SPECT/CT for Tilmanocept Localization
Presence/absence of tilmanocept localization in the hands and wrists will be summarized with frequency counts and percentages by reader and joint.
Measured: Up to 39 days
Secondary outcomes (3)
Normal Distribution of TUVjoint
Applicability of the Normal (Gaussian) distribution to TUVjoint data as assessed by normal quantile plots provided per joint and reader and p-value for the Shapiro-Wilk test of Normality.
Measured: Up to 39 days
Quantitative Evaluation of SPECT/CT
Determination of joint-specific standardized uptake value (SUV) from SPECT/CT imaging within synovial spaces of the bilateral hands and wrists in HCs and RA subjects.
Measured: Up to 39 days
Planar and SPECT/CT Comparison
Assessment of the predictive value of planar scans for SPECT/CT scans.
Measured: Up to 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start27 May 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA. Subjects will be enrolled in 1 of 2 study arms with distinct study procedures in accordance with Arm-specific eligibility requirements.
- Masking
- None (open label)
- Enrolment
- 134 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
- NCT04947137
- Sponsor's protocol ID
- NAV3-35
- Status last verified
- Mar 2022
- First submitted
- 10 May 2021
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
- ClinicalTrials.gov ID
- NCT04947137
- Acronym / sponsor ID
- NAV3-35
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA, Healthy control, Tilmanocept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Navidea BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 1 Jul 2021 (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 will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.
Detailed description
This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA.
This study is stratified into 2 arms. Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA. Subjects will be enrolled in 1 of 2 study arms with distinct study procedures in accordance with Arm-specific eligibility requirements.
| Arm | Type | Receives |
|---|---|---|
| Subjects Free of Inflammatory Disease | Experimental | Drug: Tc99m tilmanoceptThe first arm will be comprised of HCs who are deemed to be clinically free of inflammatory diseases, arthropathies, and/or arthroplasties and clinically free of joint pain for at least 28 days prior to the consent date. |
| Healthy Controls and RA Subjects on Stable Therapy | Experimental | Drug: Tc99m tilmanoceptThe second arm is comprised of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ALL SUBJECTS
- 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 has agreed to not engage in any diet, lifestyle, or medication changes until study completion.
- HEALTHY CONTROL SUBJECTS
- The subject is 30 years of age or greater at the time of consent.
Key exclusion criteria (13 listed)
- 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 therapy or chemotherapy in the past six months.
- 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.
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 |
|---|---|---|
| Tc99m tilmanoceptAlso: LymphoseekTilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. | Drug | Healthy Controls and RA Subjects on Stable Therapy, Subjects Free of Inflammatory Disease |
Primary outcome
Normal Limits of TUVjoint in Healthy Subjects
Time frame: Up to 39 days
The normal limits of TUVjoint (on a per joint basis) in HC subjects, which are defined as the 5 and 95 percentiles of TUVjoint of bilateral joints (i.e., bilateral wrists, metacarpophalangeal joint [MCPs], proximal interphalangeal [PIPs]).
Qualitative Evaluation of SPECT/CT for Tilmanocept Localization
Time frame: Up to 39 days
Presence/absence of tilmanocept localization in the hands and wrists will be summarized with frequency counts and percentages by reader and joint.
3 secondary outcomes
Normal Distribution of TUVjoint
Time frame: Up to 39 days
Quantitative Evaluation of SPECT/CT
Time frame: Up to 39 days
Planar and SPECT/CT Comparison
Time frame: Up to 39 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.
- Individual participant dataSharing planned: No
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc99m tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 7 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 13 inclusion and 13 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: finished, 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 7 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 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?
Normal Limits of TUVjoint in Healthy Subjects (time frame: Up to 39 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?
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.