Rheumatoid Arthritis
Conditions
Keywords
RA, healthy control, tilmanocept, diagnostic, imaging
Brief summary
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)?
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.
Interventions
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Sponsors
Navidea Biopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
ALL SUBJECTS: 1. The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures. 2. 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 3. The subject is between 18 and 80 years of age at the time of consent. 4. 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. 5. 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. 6. 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.
Exclusion criteria
1. The subject is pregnant or lactating. 2. The subject size or weight is not compatible with imaging per the investigator. 3. The subject has had or is currently receiving radiation therapy or chemotherapy. 4. The subject has renal insufficiency as demonstrated by a glomerular filtration rate of \< 60 mL/min. 5. 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. 6. 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. 7. The subject has a known allergy to or has had an adverse reaction to dextran exposure. 8. The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration. 9. The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to the first imaging visit (Day 0). 10. The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arms 1 & 2: Assess Camera-specific Precision of TUV | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | A SPECT/CT scan was performed at approximately 210 minutes after the tilmanocept injection on Day 8 of the trial. | 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 |
| Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | 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. | 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). |
| Arm 1 Normal Ranges of TUVjoint | Images obtained 60 minutes after tilmanocept injection on Day 0. | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Free of Inflammatory Disease Arm 1 comprised disease-free HCs. Arm 1 evaluated image/re-image consistency (repeatability and stability) of joint-specific and global TUVs across a variety of image acquisition intervals and collect normative HC data.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. | 44 |
| RA Subjects on Stable Therapy Arm 2 comprised clinically diagnosed RA subjects on stable treatment. Arm 2 evaluated image/re-image and test re-test (i.e., repeat dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. | 41 |
| RA Subjects Who Are Candidates for Initiation of a New Anti-TNFα Therapy Arm 3 comprised clinically diagnosed RA subjects on stable treatment who were candidates for new anti-TNFα therapy. Arm 3 assessed 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.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. | 31 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Missed visit | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Subject withdrew due to death in family | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Subjects Free of Inflammatory Disease | RA Subjects on Stable Therapy | RA Subjects Who Are Candidates for Initiation of a New Anti-TNFα Therapy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 31 Participants | 22 Participants | 97 Participants |
| Age, Continuous | 36.8 years STANDARD_DEVIATION 10.98 | 56.8 years STANDARD_DEVIATION 11.19 | 57.0 years STANDARD_DEVIATION 13.68 | 49.3 years STANDARD_DEVIATION 15.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 3 Participants | 15 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 38 Participants | 16 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 11 Participants | 2 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 24 Participants | 23 Participants | 28 Participants | 75 Participants |
| Region of Enrollment United States | 44 participants | 41 participants | 31 participants | 116 participants |
| Sex: Female, Male Female | 26 Participants | 34 Participants | 25 Participants | 85 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 6 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 41 | 0 / 31 |
| other Total, other adverse events | 0 / 44 | 8 / 41 | 9 / 31 |
| serious Total, serious adverse events | 0 / 44 | 0 / 41 | 2 / 31 |
Outcome results
Primary
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)
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.
Population: All Arm 3 subjects with data at the specified timepoint (Week 12 or Week 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (ESR) - Reader 1 | -0.267 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (ESR) - Reader 2 | -0.186 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Patient's Global Assessment) - Reader 1 | 0.051 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Patient's Global Assessment) - Reader 2 | 0.070 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔCDAI12w (overall) - Reader 1 | 0.248 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Physician's Global Assessment) - Reader 1 | -0.057 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Physician's Global Assessment) - Reader 2 | -0.032 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (HAQ-DI Score) - Reader 1 | 0.025 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (HAQ-DI Score) - Reader 2 | 0.083 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (HAQ-DI Score) - Reader 1 | -0.032 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (HAQ-DI Score) - Reader 2 | 0.051 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔCDAI12w (overall) - Reader 2 | 0.238 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔCDAI24w (overall) - Reader 1 | 0.115 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔCDAI24w (overall) - Reader 2 | 0.121 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Swollen Joint Count) - Reader 1 | 0.165 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Swollen Joint Count) - Reader 2 | 0.154 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ACR24w (Swollen Joint Count) - Reader 1 | 0.226 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Swollen Joint Count) - Reader 2 | 0.235 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Tender Joint Count) - Reader 1 | 0.119 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Tender Joint Count) - Reader 2 | 0.138 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Tender Joint Count) - Reader 1 | 0.161 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (Tender Joint Count) - Reader 2 | 0.194 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (ESR) - Reader 1 | -0.199 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (ESR) - Reader 2 | -0.110 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (VAS Pain Scale) - Reader 1 | 0.110 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (VAS Pain Scale) - Reader 2 | 0.105 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (VAS Pain Scale) - Reader 1 | -0.125 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR24w (VAS Pain Scale) - Reader 2 | -0.121 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Patient's Global Assessment) - Reader 1 | 0.299 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Patient's Global Assessment) - Reader 2 | 0.261 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Physician's Global Assessment) - Reader 1 | 0.137 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3: Correlation of ΔTUVglobal[5w] and Response to Therapy | ΔTUVglobal[5w] and ΔACR12w (Physician's Global Assessment) - Reader 2 | 0.115 Kendall rank correlation |
Primary
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.
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).
Population: Planned interim analysis of first 15 subjects in Arms 1 and 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.064 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.090 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.097 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.110 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.094 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 5, RMSD of TUV at 180 min A vs 180 min B | 0.097 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.058 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.068 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.159 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.080 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.091 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.067 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.071 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.078 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.050 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.090 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.057 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.050 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.087 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 5, RMSD of TUV at 180 min A vs 180 min B | 0.077 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.062 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left wrist, RMSD of TUV at 180 min A vs 180 min B | 0.085 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left wrist, RMSD of TUV at 60 min A vs 60 min B | 0.089 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.079 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.084 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.097 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.058 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.083 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.048 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.103 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.124 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 5, RMSD of TUV at 180 min A vs 180 min B | 0.076 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right wrist 5, RMSD of TUV at 60 min A vs 60 min B | 0.070 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.065 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.077 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.086 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.119 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.056 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.096 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.048 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.086 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right wrist, RMSD of TUV at 180 min A vs 180 min B | 0.087 Pixel intensity |
| Subjects Free of Inflammatory Disease | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.080 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right wrist, RMSD of TUV at 180 min A vs 180 min B | 0.163 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.125 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.130 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.070 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.080 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.066 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.099 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.077 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.043 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left wrist, RMSD of TUV at 60 min A vs 60 min B | 0.086 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.083 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.165 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.152 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.069 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.062 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.095 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.070 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 3, RMSD of TUV at 60 min A vs 60 min B | 0.059 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 4, RMSD of TUV at 60 min A vs 60 min B | 0.095 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 5, RMSD of TUV at 60 min A vs 60 min B | 0.111 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right wrist 5, RMSD of TUV at 60 min A vs 60 min B | 0.097 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.113 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.167 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.097 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.106 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 5, RMSD of TUV at 180 min A vs 180 min B | 0.114 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 1, RMSD of TUV at 60 min A vs 60 min B | 0.067 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left metacarpophalangeal 2, RMSD of TUV at 60 min A vs 60 min B | 0.124 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.106 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.075 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.131 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.083 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left proximal interphalangeal 5, RMSD of TUV at 180 min A vs 180 min B | 0.073 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Left wrist, RMSD of TUV at 180 min A vs 180 min B | 0.137 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.109 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.184 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.138 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.105 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right metacarpophalangeal 5, RMSD of TUV at 180 min A vs 180 min B | 0.078 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 1, RMSD of TUV at 180 min A vs 180 min B | 0.107 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 2, RMSD of TUV at 180 min A vs 180 min B | 0.088 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 3, RMSD of TUV at 180 min A vs 180 min B | 0.125 Pixel intensity |
| RA Subjects on Stable Therapy | Arms 1 & 2: Assess Camera-specific Precision of TUV | Right proximal interphalangeal 4, RMSD of TUV at 180 min A vs 180 min B | 0.099 Pixel intensity |
Primary
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.
Time frame: Day 0 tilmanocept injection followed by imaging at 60 minutes and 180 minutes.
Population: Planned interim analysis of first 15 subjects in Arms 1 and 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 5 TUV at 180 min | 15.155009 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 5 TUV at 60 min | 21.20135 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 1 TUV at 60 min | 12.819593 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 2 TUV at 60 min | 17.553684 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 3 TUV at 60 min | 17.847881 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 4 TUV at 60 min | 17.407371 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 5 TUV at 60 min | 14.424961 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left wrist TUV at 60 min | 14.401304 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 1 TUV at 60 min | 13.628956 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 2 TUV at 60 min | 19.774959 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 3 TUV at 60 min | 20.228576 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 4 TUV at 60 min | 18.728588 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 5 TUV at 60 min | 19.283062 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 1 TUV at 60 min | 14.308134 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 2 TUV at 60 min | 18.710387 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Global TUV at 60 min | 263.31 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 1 TUV at 60 min | 16.92295 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 2 TUV at 60 min | 19.613096 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 3 TUV at 60 min | 18.651035 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 4 TUV at 60 min | 18.511573 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right wrist TUV at 180 min | 16.823037 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 3 TUV at 60 min | 14.969821 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 4 TUV at 60 min | 18.369256 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 5 TUV at 60 min | 18.873772 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right wrist TUV at 60 min | 13.05914 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Global TUV at 180 min | 355.82 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 1 TUV at 180 min | 19.4363 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 2 TUV at 180 min | 21.914899 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 3 TUV at 180 min | 24.269644 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 4 TUV at 180 min | 23.438328 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 5 TUV at 180 min | 21.045602 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 1 TUV at 180 min | 18.335106 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 2 TUV at 180 min | 19.144279 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 3 TUV at 180 min | 16.707115 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 4 TUV at 180 min | 20.968296 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left wrist TUV at 180 min | 17.46611 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 1 TUV at 180 min | 18.333323 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 2 TUV at 180 min | 19.876281 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 3 TUV at 180 min | 19.314268 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 4 TUV at 180 min | 21.176376 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 5 TUV at 180 min | 21.480266 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 1 TUV at 180 min | 16.290041 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 2 TUV at 180 min | 18.330801 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 3 TUV at 180 min | 17.515896 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 4 TUV at 180 min | 20.621393 Coefficient of variation |
| Subjects Free of Inflammatory Disease | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 5 TUV at 180 min | 18.927298 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 5 TUV at 60 min | 16.805949 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 4 TUV at 60 min | 13.970308 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 5 TUV at 180 min | 12.16714 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 5 TUV at 60 min | 12.21378 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right wrist TUV at 60 min | 10.202857 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 1 TUV at 60 min | 11.370952 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 2 TUV at 180 min | 11.916304 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 2 TUV at 60 min | 9.7087077 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Global TUV at 180 min | 287.80 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 3 TUV at 60 min | 12.604637 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left wrist TUV at 180 min | 10.10065 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 4 TUV at 60 min | 15.660407 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 1 TUV at 180 min | 12.081512 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 5 TUV at 60 min | 10.066291 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 5 TUV at 180 min | 13.444692 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left wrist TUV at 60 min | 8.7901247 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 2 TUV at 180 min | 19.814146 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 1 TUV at 60 min | 11.48462 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 1 TUV at 180 min | 12.726762 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 2 TUV at 60 min | 18.014491 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 3 TUV at 180 min | 15.786226 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 3 TUV at 60 min | 23.49369 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 4 TUV at 180 min | 16.172441 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 4 TUV at 60 min | 18.207621 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 4 TUV at 180 min | 17.776583 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 5 TUV at 60 min | 12.958136 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 2 TUV at 180 min | 16.017255 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 1 TUV at 60 min | 11.080537 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 5 TUV at 180 min | 14.647724 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 1 TUV at 180 min | 10.408102 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Global TUV at 60 min | 208.79 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 1 TUV at 180 min | 15.40672 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 1 TUV at 60 min | 13.189704 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 3 TUV at 180 min | 19.791295 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 2 TUV at 60 min | 20.477108 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 2 TUV at 180 min | 10.324402 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left metacarpophalangeal 3 TUV at 60 min | 16.378147 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 3 TUV at 180 min | 10.748883 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 3 TUV at 180 min | 11.347808 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right wrist TUV at 180 min | 10.559086 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 2 TUV at 60 min | 12.508548 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right metacarpophalangeal 4 TUV at 180 min | 18.332795 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 3 TUV at 60 min | 12.831644 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Left proximal interphalangeal 4 TUV at 180 min | 11.384086 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 4 TUV at 60 min | 16.271218 Coefficient of variation |
| RA Subjects on Stable Therapy | Arms 1 and 2: Stability of the Mean/Variance Relationship | Right proximal interphalangeal 5 TUV at 180 min | 14.872591 Coefficient of variation |
Primary
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
Time frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and Day 8
Population: All Arm 2 subjects with evaluable images at Days 0 and 8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.288 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right wrist, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.081 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.135 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.151 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.221 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.179 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.235 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.263 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.198 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.172 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.229 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.233 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left wrist, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.107 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.142 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.134 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.131 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.208 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.213 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.221 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.227 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.212 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.261 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.244 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right wrist, RMSD of TUV at Day 0 vs Day 8, Reader 1, Anterior view | 0.078 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.180 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.170 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.148 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.130 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.180 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.346 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.245 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.160 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.202 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.242 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left wrist, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.106 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.137 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.120 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.124 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.159 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.165 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.237 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.172 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.219 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.271 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right wrist, RMSD of TUV at Day 0 vs Day 8, Reader 2, Anterior view | 0.084 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.251 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.229 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.225 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.224 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.357 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.303 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.254 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.251 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.240 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.313 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left wrist, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.180 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.214 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.143 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.188 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.247 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.307 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.253 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.221 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.246 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.367 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right wrist, RMSD of TUV at Day 0 vs Day 8, Reader 1, Posterior view | 0.133 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.112 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.112 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.105 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.109 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.152 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.227 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.133 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.183 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.205 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.281 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Left wrist, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.081 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.149 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.141 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.132 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.137 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right metacarpophalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.165 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 1, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 1.834 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 2, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.178 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 3, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.199 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 4, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.200 Pixel intensity |
| Subjects Free of Inflammatory Disease | Longitudinal (8-day) Variation of TUV | Right proximal interphalangeal 5, RMSD of TUV at Day 0 vs Day 8, Reader 2, Posterior view | 0.215 Pixel intensity |
Secondary
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)
Time frame: Images obtained 60 minutes after tilmanocept injection on Day 0.
Population: Healthy control subjects with evaluable scans. Unevaluable scans included those with poor hand placement/positioning and low signal (overlapping with background) in most of the fingers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 1, Posterior View, Reader 1 | 0.80 Pixel intensity | Standard Deviation 0.161 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 4, Posterior View, Reader 1 | 0.80 Pixel intensity | Standard Deviation 0.144 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 1, Anterior View, Reader 1 | 1.01 Pixel intensity | Standard Deviation 0.213 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 1, Anterior View, Reader 2 | 1.20 Pixel intensity | Standard Deviation 0.257 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 1, Posterior View, Reader 1 | 1.05 Pixel intensity | Standard Deviation 0.185 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 1, Posterior View, Reader 2 | 1.33 Pixel intensity | Standard Deviation 0.2 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 2, Anterior View, Reader 1 | 0.85 Pixel intensity | Standard Deviation 0.169 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 2, Anterior View, Reader 2 | 0.92 Pixel intensity | Standard Deviation 0.18 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 2, Posterior View, Reader 1 | 0.86 Pixel intensity | Standard Deviation 0.158 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 2, Posterior View, Reader 2 | 1.00 Pixel intensity | Standard Deviation 0.17 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 3, Anterior View, Reader 1 | 0.79 Pixel intensity | Standard Deviation 0.158 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 3, Anterior View, Reader 2 | 0.90 Pixel intensity | Standard Deviation 0.197 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 3, Posterior View, Reader 1 | 0.86 Pixel intensity | Standard Deviation 0.186 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 3, Posterior View, Reader 2 | 1.04 Pixel intensity | Standard Deviation 0.174 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 4, Anterior View, Reader 1 | 0.77 Pixel intensity | Standard Deviation 0.192 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 4, Anterior View, Reader 2 | 0.90 Pixel intensity | Standard Deviation 0.201 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 4, Posterior View, Reader 2 | 1.01 Pixel intensity | Standard Deviation 0.161 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 5, Anterior View, Reader 1 | 0.73 Pixel intensity | Standard Deviation 0.186 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 5, Anterior View, Reader 2 | 0.82 Pixel intensity | Standard Deviation 0.189 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 5, Posterior View, Reader 1 | 0.80 Pixel intensity | Standard Deviation 0.162 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Metacarpophalangeal 5, Posterior View, Reader 2 | 0.92 Pixel intensity | Standard Deviation 0.169 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 1, Anterior View, Reader 1 | 0.75 Pixel intensity | Standard Deviation 0.158 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 1, Anterior View, Reader 2 | 0.89 Pixel intensity | Standard Deviation 0.192 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 1, Posterior View, Reader 1 | 0.79 Pixel intensity | Standard Deviation 0.175 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 1, Posterior View, Reader 2 | 0.93 Pixel intensity | Standard Deviation 0.166 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 2, Anterior View, Reader 1 | 0.71 Pixel intensity | Standard Deviation 0.17 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 2, Anterior View, Reader 2 | 0.77 Pixel intensity | Standard Deviation 0.179 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 2, Posterior View, Reader 1 | 0.68 Pixel intensity | Standard Deviation 0.129 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 2, Posterior View, Reader 2 | 0.79 Pixel intensity | Standard Deviation 0.155 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 3, Anterior View, Reader 1 | 0.70 Pixel intensity | Standard Deviation 0.184 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 3, Anterior View, Reader 2 | 0.73 Pixel intensity | Standard Deviation 0.192 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 3, Posterior View, Reader 1 | 0.69 Pixel intensity | Standard Deviation 0.126 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 3, Posterior View, Reader 2 | 0.82 Pixel intensity | Standard Deviation 0.146 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 4, Anterior View, Reader 1 | 0.66 Pixel intensity | Standard Deviation 0.143 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 4, Anterior View, Reader 2 | 0.72 Pixel intensity | Standard Deviation 0.167 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 4, Posterior View, Reader 1 | 0.64 Pixel intensity | Standard Deviation 0.128 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 4, Posterior View, Reader 2 | 0.75 Pixel intensity | Standard Deviation 0.156 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 5, Anterior View, Reader 1 | 0.59 Pixel intensity | Standard Deviation 0.147 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 5, Anterior View, Reader 2 | 0.66 Pixel intensity | Standard Deviation 0.141 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 5, Posterior View, Reader 1 | 0.59 Pixel intensity | Standard Deviation 0.124 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Proximal Interphalangeal 5, Posterior View, Reader 2 | 0.69 Pixel intensity | Standard Deviation 0.135 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Wrist, Anterior View, Reader 1 | 1.32 Pixel intensity | Standard Deviation 0.229 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Wrist, Anterior View, Reader 2 | 1.48 Pixel intensity | Standard Deviation 0.243 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Wrist, Posterior View, Reader 1 | 1.40 Pixel intensity | Standard Deviation 0.183 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Left Wrist, Posterior View, Reader 2 | 1.66 Pixel intensity | Standard Deviation 0.18 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 1, Anterior View, Reader 1 | 0.98 Pixel intensity | Standard Deviation 0.185 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 1, Anterior View, Reader 2 | 1.17 Pixel intensity | Standard Deviation 0.244 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 1, Posterior View, Reader 1 | 1.04 Pixel intensity | Standard Deviation 0.19 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 1, Posterior View, Reader 2 | 1.29 Pixel intensity | Standard Deviation 0.297 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 2, Anterior View, Reader 1 | 0.87 Pixel intensity | Standard Deviation 0.18 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 2, Anterior View, Reader 2 | 0.88 Pixel intensity | Standard Deviation 0.181 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 2, Posterior View, Reader 1 | 0.94 Pixel intensity | Standard Deviation 0.206 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 2, Posterior View, Reader 2 | 1.00 Pixel intensity | Standard Deviation 0.182 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 3, Anterior View, Reader 1 | 0.83 Pixel intensity | Standard Deviation 0.176 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 3, Anterior View, Reader 2 | 0.91 Pixel intensity | Standard Deviation 0.191 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 3, Posterior View, Reader 1 | 0.86 Pixel intensity | Standard Deviation 0.143 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 3, Posterior View, Reader 2 | 1.02 Pixel intensity | Standard Deviation 0.189 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 4, Anterior View, Reader 1 | 0.83 Pixel intensity | Standard Deviation 0.214 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 4, Anterior View, Reader 2 | 0.94 Pixel intensity | Standard Deviation 0.216 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 4, Posterior View, Reader 1 | 0.83 Pixel intensity | Standard Deviation 0.141 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 4, Posterior View, Reader 2 | 1.02 Pixel intensity | Standard Deviation 0.199 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 5, Anterior View, Reader 1 | 0.74 Pixel intensity | Standard Deviation 0.174 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 5, Anterior View, Reader 2 | 0.86 Pixel intensity | Standard Deviation 0.212 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 5, Posterior View, Reader 1 | 0.78 Pixel intensity | Standard Deviation 0.156 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Metacarpophalangeal 5, Posterior View, Reader 2 | 0.96 Pixel intensity | Standard Deviation 0.2 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 1, Anterior View, Reader 1 | 0.79 Pixel intensity | Standard Deviation 0.162 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 1, Anterior View, Reader 2 | 0.89 Pixel intensity | Standard Deviation 0.198 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 1, Posterior View, Reader 2 | 0.95 Pixel intensity | Standard Deviation 0.155 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 2, Anterior View, Reader 1 | 0.68 Pixel intensity | Standard Deviation 0.14 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 2, Anterior View, Reader 2 | 0.75 Pixel intensity | Standard Deviation 0.159 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 2, Posterior View, Reader 1 | 0.73 Pixel intensity | Standard Deviation 0.114 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 2, Posterior View, Reader 2 | 0.79 Pixel intensity | Standard Deviation 0.129 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 3, Anterior View, Reader 1 | 0.66 Pixel intensity | Standard Deviation 0.164 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 3, Anterior View, Reader 2 | 0.73 Pixel intensity | Standard Deviation 0.183 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 3, Posterior View, Reader 1 | 0.71 Pixel intensity | Standard Deviation 0.118 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Wrist, Anterior View, Reader 1 | 1.35 Pixel intensity | Standard Deviation 0.221 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 3, Posterior View, Reader 2 | 0.80 Pixel intensity | Standard Deviation 0.139 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 4, Anterior View, Reader 1 | 0.67 Pixel intensity | Standard Deviation 0.196 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 4, Anterior View, Reader 2 | 0.73 Pixel intensity | Standard Deviation 0.172 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 4, Posterior View, Reader 1 | 0.65 Pixel intensity | Standard Deviation 0.132 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 4, Posterior View, Reader 2 | 0.73 Pixel intensity | Standard Deviation 0.142 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 5, Anterior View, Reader 1 | 0.58 Pixel intensity | Standard Deviation 0.141 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 5, Anterior View, Reader 2 | 0.66 Pixel intensity | Standard Deviation 0.135 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 5, Posterior View, Reader 1 | 0.55 Pixel intensity | Standard Deviation 0.093 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Proximal Interphalangeal 5, Posterior View, Reader 2 | 0.66 Pixel intensity | Standard Deviation 0.122 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Wrist, Anterior View, Reader 2 | 1.51 Pixel intensity | Standard Deviation 0.253 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Wrist, Posterior View, Reader 1 | 1.41 Pixel intensity | Standard Deviation 0.188 |
| Subjects Free of Inflammatory Disease | Arm 1 Normal Ranges of TUVjoint | Right Wrist, Posterior View, Reader 2 | 1.65 Pixel intensity | Standard Deviation 0.264 |
Secondary
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).
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.
Population: All Arm 3 subjects with data at the specified timepoint (Week 12 or Week 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Patient's Global Assessment) - Reader 1 | -0.070 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔCDAI12w (overall) - Reader 1 | -0.045 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔCDAI24w (overall) - Reader 1 | 0.072 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Swollen Joint Count) - Reader 1 | -0.100 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Swollen Joint Count) - Reader 1 | -0.067 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Tender Joint Count) - Reader 1 | -0.086 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Tender Joint Count) - Reader 1 | 0.130 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (ESR) - Reader 1 | -0.176 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (ESR) - Reader 1 | -0.261 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (VAS Pain Scale) - Reader 1 | -0.099 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (VAS Pain Scale) - Reader 1 | -0.062 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Patient's Global Assessment) - Reader 1 | -0.096 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Physician's Global Assessment) - Reader 1 | 0.121 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Physician's Global Assessment) - Reader 1 | 0.057 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔCDAI12w (overall) - Reader 2 | -0.029 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔCDAI24w (overall) - Reader 2 | 0.109 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Swollen Joint Count) - Reader 2 | -0.073 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Swollen Joint Count) - Reader 2 | -0.025 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Tender Joint Count) - Reader 2 | -0.057 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Tender Joint Count) - Reader 2 | 0.175 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (ESR) - Reader 2 | -0.145 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (ESR) - Reader 2 | -0.234 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (VAS Pain Scale) - Reader 2 | -0.110 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (VAS Pain Scale) - Reader 2 | -0.028 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Patient's Global Assessment) - Reader 2 | -0.096 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Patient's Global Assessment) - Reader 2 | -0.038 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR12w (Physician's Global Assessment) - Reader 2 | 0.110 Kendall rank correlation |
| Subjects Free of Inflammatory Disease | Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) | TUVglobal[baseline] and ΔACR24w (Physician's Global Assessment) - Reader 2 | 0.064 Kendall rank correlation |
Secondary
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
Time frame: A SPECT/CT scan was performed at approximately 210 minutes after the tilmanocept injection on Day 8 of the trial.
Population: All Arm 2 subjects who received SPECT/CT scan
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Free of Inflammatory Disease | 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 | 0 Percent of participants |