Rheumatoid ArthritisPhase 2NCT03938636

Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging

A Phase 2 study testing Tc 99m tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
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: 116 participants
Where: 10 sitesUnited States
Study dates: 8 Apr 2019to 30 Jun 2021
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.
ARMS 1 and 2 (only): The subject has agreed to not engage in any diet, lifestyle, or medication changes until study completion.
HEALTHY CONTROL SUBJECTS
The subject is between 18 and 80 years of age at the time of consent.
The subject is deemed to be clinically free of any inflammatory disease(s) 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 NSAIDs) and has not taken 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 first imaging visit (Day 0).
7. If the subject is receiving bDMARD or janus kinase (JAK) inhibitor therapy, they have been at a stable dose > 180 days prior to the first imaging visit (Day 0).
8. If the subject is receiving NSAIDs or oral corticosteroids, the dose has been stable for > 28 days prior to first imaging visit (Day 1). The corticosteroid dose must be ≤ 10 mg/day of prednisone or an equivalent steroid dose.
9. ARM 3 (only): The subject is receiving anti-rheumatic treatment and is a candidate for initiation of, or change to, a new anti-TNFα bDMARD treatment.

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.
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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University Hospitals
Cleveland, Ohio, 44106
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Kettering Medical Center
Kettering, Ohio, 45429
Physician Research Collaboration
Lincoln, Nebraska, 68516
Axis Clinical Trials
Los Angeles, California, 90036
Innovation Medical Research Center
Palmetto Bay, Florida, 33157
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California San Francisco
San Francisco, California, 94110
Imaging Endpoints
Scottsdale, Arizona, 85258
Central States Research
Tulsa, Oklahoma, 74136

Other trials in United States

About this study

This clinical trial will look at scans of the hands and wrists taken from healthy control subjects (HCs) and from subjects with rheumatoid arthritis (RA). Before each scan, subjects will be given an injection of Tc 99m tilmanocept to help the scan identify inflammation in the hand and wrist joints, which can be a part of the RA disease. Data from the scans will be used to calculate a number referred to as tilmanocept uptake value (or TUV) that is a measure of how much Tc 99m tilmanocept has located in the joints. The questions this trial aims to answer are:

How consistent are the scan results (TUVs) when the scans are repeated over time?
What are normal TUVs in healthy people? This will help define abnormally high values in people with RA.
Are TUVs calculated early after a person starts a new drug to treat RA able to predict whether that person will have a good response to the drug later on (after it has had time to take full effect several weeks later)?

Read the detailed description

This trial is a prospective, open-label, multicenter, single and repeated-dose study designed to evaluate the reliability and sensitivity of TUV assessments in healthy control subjects and subjects with active RA.

This study is stratified into 3 arms. The first 2 arms, consisting of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment, respectively, are designed to evaluate the image re-image and/or test re-test (i.e., repeated dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals.

The third arm consists of clinically-diagnosed subjects with active RA who are candidates for initiation of, or change to, a new anti-TNFα bDMARD therapy. This arm is designed to assess the efficacy of TUVglobal as an early predictor of response to the new anti-TNFα bDMARD therapy.

Conditions: Rheumatoid Arthritis
Being tested: Tc 99m tilmanocept
Keywords: RA, healthy control, tilmanocept, diagnostic, imaging
Medical subject headings: Arthritis, Rheumatoid, Disease

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 groups in NCT03938636
Study group	Role	What they receive
Subjects free of inflammatory disease	Experimental	Arm 1 includes inflammatory-disease-free HCs. Arm 1 was designed to evaluate image/re-image consistency (repeatability and stability) of joint-specific and global TUVs across a variety of image acquisition intervals and to collect normative HC data. Receives: Drug: Tc 99m tilmanocept
RA subjects on stable therapy	Experimental	Arm 2 includes clinically-diagnosed RA subjects on stable treatment. Arm 2 was designed to evaluate image/re-image and test re-test (i.e., repeated dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals. Receives: Drug: Tc 99m tilmanocept
RA subjects who are candidates for initiation of a new anti-TNFα therapy	Experimental	Arm 3 includes clinically-diagnosed RA subjects on stable treatment who are candidates for initiation of, or change to, new anti-TNFα therapy. Arm 3 was designed to assess the efficacy of global TUVs, obtained before and after initiation of a new anti-TNFα therapy, to predict future clinical responsiveness to the new therapy. Receives: Drug: Tc 99m tilmanocept

What is being measured

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

Arms 1 & 2: Assess Camera-specific Precision of TUV
The camera-specific precision of TUVjoint in subjects with active RA and Healthy Controls (HCs), which is described as the Root Mean Square Difference (RMSD) between the 15-minute planar images (referred to as A and B images at 60 and 180 minutes). The RMSD is calculated as the square root of the mean squared deviation from zero.
Measured: Day 0 tilmanocept injection followed by imaging at 60 minutes (60A) and 75 minutes (60B) and at 180 minutes (180A) and 195 minutes (180B).
Arms 1 and 2: Stability of the Mean/Variance Relationship
The stability of the mean/variance relationship, which is assessed by comparing the Coefficient of Variation (CV) of TUVjoint and TUVglobal in subjects with active RA and in healthy control subjects at 60 and 180 minutes.
Measured: Day 0 tilmanocept injection followed by imaging at 60 minutes and 180 minutes.
Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy
The Kendall rank correlation of the change in global TUV from baseline to 5 weeks (ΔTUVglobal[5w]) and response to new anti-TNFα bDMARD therapy defined by the change from baseline of CDAI to 12 ± 1 weeks and 24 ± 1 weeks (ΔCDAI12w and ΔCDAI24w).• The Kendall rank correlation of ΔTUVglobal[5w] and response to new anti-TNFα bDMARD therapy from baseline to 12 ± 1 weeks and 24 ± 1 weeks defined by ACR Response Criteria (ΔACR12w and ΔACR24w)
Measured: Imaging (60 minutes after tilmanocept injection) on Day 0 and at 5 weeks after new therapy initiation; Assessment of CDAI and ACR Response Criteria at 12 and 24 weeks after new therapy initiation.
Longitudinal (8-day) Variation of TUV
Longitudinal (8-day) variation of TUV analyzed for each DAS28 joint, defined as the root mean square deviation (RMSD) and 95% confidence interval for the RMSD for each joint at Day 0 vs Day 8
Measured: Imaging (60 minutes after tilmanocept injection) on Day 0 and Day 8

Secondary outcomes (3)

Arm 1 Normal Ranges of TUVjoint
The normal range of tilmanocept uptake values (TUVs) in hand and wrist joints of healthy control subjects, expressed as the mean and standard deviation. TUV is defined as the average pixel intensity of the region of interest (hand or wrist joint) divided by the average pixel intensity of the reference region (includes the region from one wrist region of interest diameter above the wrist region of interest down to the fingertips)
Measured: Images obtained 60 minutes after tilmanocept injection on Day 0.
Qualitative Evaluations of SPECT/CT as an Indication of Bone Involvement Rather Than Localization Within the Synovial Space in the Hands and Wrists of Arm 2 Subjects
Percent of Arm 2 subjects who had SPECT/CT scans who were determined to have bone involvement rather than localization within the synovial space of the hands and wrists
Measured: A SPECT/CT scan was performed at approximately 210 minutes after the tilmanocept injection on Day 8 of the trial.
Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy)
The correlation of the TUVglobal[baseline] 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 (ΔCDAI12w and ΔCDAI24w, respectively) and by ACR Response Criteria (ACR12w and ACR24w, respectively).
Measured: Images were obtained 60 minutes after tilmanocept injection on Day 0. New anti-TNFα therapy was initiated after completion of Day 0 procedures. CDAI and ACR were assessed on Day 0 and again 12 and 24 weeks after initiation of new anti-TNFα therapy.

Timeline

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

8 Apr 201930 Jun 2021

First posted6 May 2019
Study start8 Apr 2019
Primary completion8 Feb 2021
Study completion30 Jun 2021

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 and repeated-dose study designed to evaluate the reliability and sensitivity of TUV assessments in healthy controls and subjects with active RA.
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03938636
Sponsor's protocol ID: NAV3-31
Status last verified: Aug 2023
First submitted: 24 Apr 2019
Last updated: 24 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
ClinicalTrials.gov ID: NCT03938636
Acronym / sponsor ID: NAV3-31
Conditions: Rheumatoid Arthritis
Keywords: RA, healthy control, tilmanocept, diagnostic, imaging
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Navidea BiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 8 Apr 2019 (actual)
Primary completion: 8 Feb 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 6 May 2019 (actual)
Results: Posted 24 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

How consistent are the scan results (TUVs) when the scans are repeated over time?
What are normal TUVs in healthy people? This will help define abnormally high values in people with RA.
Are TUVs calculated early after a person starts a new drug to treat RA able to predict whether that person will have a good response to the drug later on (after it has had time to take full effect several weeks later)?

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is a prospective, open-label, multicenter, single and repeated-dose study designed to evaluate the reliability and sensitivity of TUV assessments in healthy controls and subjects with active RA.

Arm	Type	Receives
Subjects free of inflammatory disease	Experimental	Drug: Tc 99m tilmanoceptArm 1 includes inflammatory-disease-free HCs. Arm 1 was designed to evaluate image/re-image consistency (repeatability and stability) of joint-specific and global TUVs across a variety of image acquisition intervals and to collect normative HC data.
RA subjects on stable therapy	Experimental	Drug: Tc 99m tilmanoceptArm 2 includes clinically-diagnosed RA subjects on stable treatment. Arm 2 was designed to evaluate image/re-image and test re-test (i.e., repeated dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals.
RA subjects who are candidates for initiation of a new anti-TNFα therapy	Experimental	Drug: Tc 99m tilmanoceptArm 3 includes clinically-diagnosed RA subjects on stable treatment who are candidates for initiation of, or change to, new anti-TNFα therapy. Arm 3 was designed to assess the efficacy of global TUVs, obtained before and after initiation of a new anti-TNFα therapy, to predict future clinical responsiveness to the new therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
ARMS 1 and 2 (only): The subject has agreed to not engage in any diet, lifestyle, or medication changes until study completion.
HEALTHY CONTROL SUBJECTS
The subject is between 18 and 80 years of age at the time of consent.
The subject is deemed to be clinically free of any inflammatory disease(s) and has not experienced joint pain for at least 28 days prior to the consent date.

Key exclusion criteria (10 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, RA subjects who are candidates for initiation of a new anti-TNFα therapy, Subjects free of inflammatory disease

Primary outcome

Arms 1 & 2: Assess Camera-specific Precision of TUV
Time frame: Day 0 tilmanocept injection followed by imaging at 60 minutes (60A) and 75 minutes (60B) and at 180 minutes (180A) and 195 minutes (180B).
The camera-specific precision of TUVjoint in subjects with active RA and Healthy Controls (HCs), which is described as the Root Mean Square Difference (RMSD) between the 15-minute planar images (referred to as A and B images at 60 and 180 minutes). The RMSD is calculated as the square root of the mean squared deviation from zero.
Arms 1 and 2: Stability of the Mean/Variance Relationship
Time frame: Day 0 tilmanocept injection followed by imaging at 60 minutes and 180 minutes.
The stability of the mean/variance relationship, which is assessed by comparing the Coefficient of Variation (CV) of TUVjoint and TUVglobal in subjects with active RA and in healthy control subjects at 60 and 180 minutes.
Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy
Time frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and at 5 weeks after new therapy initiation; Assessment of CDAI and ACR Response Criteria at 12 and 24 weeks after new therapy initiation.
The Kendall rank correlation of the change in global TUV from baseline to 5 weeks (ΔTUVglobal[5w]) and response to new anti-TNFα bDMARD therapy defined by the change from baseline of CDAI to 12 ± 1 weeks and 24 ± 1 weeks (ΔCDAI12w and ΔCDAI24w).• The Kendall rank correlation of ΔTUVglobal[5w] and response to new anti-TNFα bDMARD therapy from baseline to 12 ± 1 weeks and 24 ± 1 weeks defined by ACR Response Criteria (ΔACR12w and ΔACR24w)
Longitudinal (8-day) Variation of TUV
Time frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and Day 8
Longitudinal (8-day) variation of TUV analyzed for each DAS28 joint, defined as the root mean square deviation (RMSD) and 95% confidence interval for the RMSD for each joint at Day 0 vs Day 8

3 secondary outcomes

Arm 1 Normal Ranges of TUVjoint
Time frame: Images obtained 60 minutes after tilmanocept injection on Day 0.
Qualitative Evaluations of SPECT/CT as an Indication of Bone Involvement Rather Than Localization Within the Synovial Space in the Hands and Wrists of Arm 2 Subjects
Time frame: A SPECT/CT scan was performed at approximately 210 minutes after the tilmanocept injection on Day 8 of the trial.
Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy)
Time frame: Images were obtained 60 minutes after tilmanocept injection on Day 0. New anti-TNFα therapy was initiated after completion of Day 0 procedures. CDAI and ACR were assessed on Day 0 and again 12 and 24 weeks after initiation of new anti-TNFα therapy.

Results and safety

Results posted to the registry on 24 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Free of Inflammatory Disease	44	44
RA Subjects on Stable Therapy	41	38
Candidates for Initiation of a New Anti-TNFα Therapy	31	28

Primary outcome: Arms 1 & 2: Assess Camera-specific Precision of TUV

Time frame: Day 0 tilmanocept injection followed by imaging at 60 minutes (60A) and 75 minutes (60B) and at 180 minutes (180A) and 195 minutes (180B).. Number (95% Confidence Interval). Unit: Pixel intensity

Measure	Subjects Free of Inflammatory Disease n = 15	RA Subjects on Stable Therapy n = 15
Left metacarpophalangeal 1, RMSD of TUV at 60 min A vs 60 min B	0.159 (0.11 to 0.23)	0.067 (0.05 to 0.10)
Left metacarpophalangeal 2, RMSD of TUV at 60 min A vs 60 min B	0.091 (0.07 to 0.14)	0.124 (0.09 to 0.19)
Left metacarpophalangeal 3, RMSD of TUV at 60 min A vs 60 min B	0.087 (0.06 to 0.13)	0.125 (0.09 to 0.19)
Left metacarpophalangeal 4, RMSD of TUV at 60 min A vs 60 min B	0.094 (0.07 to 0.14)	0.130 (0.09 to 0.20)
Left metacarpophalangeal 5, RMSD of TUV at 60 min A vs 60 min B	0.077 (0.06 to 0.12)	0.070 (0.05 to 0.09)
Left proximal interphalangeal 1, RMSD of TUV at 60 min A vs 60 min B	0.078 (0.05 to 0.11)	0.080 (0.05 to 0.10)
Left proximal interphalangeal 2, RMSD of TUV at 60 min A vs 60 min B	0.058 (0.04 to 0.09)	0.066 (0.05 to 0.10)
Left proximal interphalangeal 3, RMSD of TUV at 60 min A vs 60 min B	0.064 (0.05 to 0.10)	0.099 (0.07 to 0.14)

Population analysed: Planned interim analysis of first 15 subjects in Arms 1 and 2

Primary outcome: Arms 1 and 2: Stability of the Mean/Variance Relationship

Time frame: Day 0 tilmanocept injection followed by imaging at 60 minutes and 180 minutes.. Number. Unit: Coefficient of variation

Measure	Subjects Free of Inflammatory Disease n = 15	RA Subjects on Stable Therapy n = 15
Global TUV at 60 min	263.31	208.79
Left metacarpophalangeal 1 TUV at 60 min	16.92295	13.189704
Left metacarpophalangeal 2 TUV at 60 min	19.613096	20.477108
Left metacarpophalangeal 3 TUV at 60 min	18.651035	16.378147
Left metacarpophalangeal 4 TUV at 60 min	18.511573	13.970308
Left metacarpophalangeal 5 TUV at 60 min	21.20135	12.21378
Left proximal interphalangeal 1 TUV at 60 min	12.819593	11.370952
Left proximal interphalangeal 2 TUV at 60 min	17.553684	9.7087077

Population analysed: Planned interim analysis of first 15 subjects in Arms 1 and 2

Primary outcome: Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy

Time frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and at 5 weeks after new therapy initiation; Assessment of CDAI and ACR Response Criteria at 12 and 24 weeks after new therapy initiation.. Number (95% Confidence Interval). Unit: Kendall rank correlation

Measure	RA Subjects Who Are Candidates for Initiation of a New Anti-TNFα Therapy n = 29
ΔTUVglobal[5w] and ΔCDAI12w (overall) - Reader 1	0.248 (0.003 to 0.494)
ΔTUVglobal[5w] and ΔCDAI12w (overall) - Reader 2	0.238 (0.002 to 0.474)
ΔTUVglobal[5w] and ΔCDAI24w (overall) - Reader 1	0.115 (-0.221 to 0.452)
ΔTUVglobal[5w] and ΔCDAI24w (overall) - Reader 2	0.121 (-0.207 to 0.449)
ΔTUVglobal[5w] and ΔACR12w (Swollen Joint Count) - Reader 1	0.165 (-0.077 to 0.407)
ΔTUVglobal[5w] and ΔACR12w (Swollen Joint Count) - Reader 2	0.154 (-0.096 to 0.405)
ΔTUVglobal[5w] and ACR24w (Swollen Joint Count) - Reader 1	0.226 (-0.024 to 0.476)
ΔTUVglobal[5w] and ΔACR24w (Swollen Joint Count) - Reader 2	0.235 (-0.013 to 0.483)

Population analysed: All Arm 3 subjects with data at the specified timepoint (Week 12 or Week 24)

Primary outcome: Longitudinal (8-day) Variation of TUV

Time frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and Day 8. Number (95% Confidence Interval). Unit: Pixel intensity

Measure	Arm 2 RA Subjects on Stable Therapy n = 35
Left metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.135 (0.109 to 0.175)
Left metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.151 (0.122 to 0.196)
Left metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.221 (0.174 to 0.280)
Left metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.179 (0.145 to 0.234)
Left metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.235 (0.186 to 0.299)
Left proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.263 (0.213 to 0.342)
Left proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.198 (0.160 to 0.257)
Left proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view	0.172 (0.139 to 0.224)

Population analysed: All Arm 2 subjects with evaluable images at Days 0 and 8

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Untoward medical events beginning on Visit 2 (Day 0) until the final visit (variable per arm) were reported as adverse events. For subjects in Arms 1 and 2, the final visit (Visit 5) occurred on Day 8 to 12. For subjects in Arm 3, the final visit (Visit 9) occurred on Week 24 to 26.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Free of Inflammatory Disease	0 of 44 (0%)	0 of 44 (0%)	0 of 44
RA Subjects on Stable Therapy	0 of 41 (0%)	8 of 41 (19.5%)	0 of 41
RA Subjects Who Are Candidates for Initiation of a New Anti-TNFα Therapy	2 of 31 (6.5%)	9 of 31 (29%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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

10 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 Tc 99m tilmanocept in people with Rheumatoid Arthritis, run by Navidea Biopharmaceuticals at 10 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 16 inclusion and 10 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 24 Aug 2023). 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?

Arms 1 & 2: Assess Camera-specific Precision of TUV (time frame: Day 0 tilmanocept injection followed by imaging at 60 minutes (60A) and 75 minutes (60B) and at 180 minutes (180A) and 195 minutes (180B).). The study lists 4 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 NCT03938636.

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 24 Aug 2023.