Trial Outcomes & Findings for Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept (NCT NCT04947137)
NCT ID: NCT04947137
Last Updated: 2025-01-08
Results Overview
The normal limits of TUVjoint (on a per joint basis) in HC subjects, which are defined as the 5 and 95 percentiles of TUVjoint of bilateral joints (i.e., bilateral wrists, metacarpophalangeal joint \[MCPs\], proximal interphalangeal \[PIPs\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
Up to 39 days
Results posted on
2025-01-08
Participant Flow
Participant milestones
| Measure |
Subjects Free of Inflammatory Disease
Arm 1 includes HCs who are deemed to be clinically free of inflammatory diseases, arthropathies, and/or arthroplasties and clinically free of joint pain for at least 28 days prior to the consent date.
Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
Healthy Controls and RA Subjects on Stable Therapy
Arm 2 includes \[1\] disease-free HCs and \[2\] clinically diagnosed RA subjects on stable treatment.
Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
14
|
|
Overall Study
COMPLETED
|
120
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
Baseline characteristics by cohort
| Measure |
Subjects Free of Inflammatory Disease
n=120 Participants
Arm 1 includes HCs who are deemed to be clinically free of inflammatory diseases, arthropathies, and/or arthroplasties and clinically free of joint pain for at least 28 days prior to the consent date.
Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
Healthy Controls and RA Subjects on Stable Therapy
n=14 Participants
Arm 2 includes \[1\] disease-free HCs and \[2\] clinically diagnosed RA subjects on stable treatment.
Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
n=5 Participants
|
54.8 years
n=7 Participants
|
54.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
73 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 39 daysPopulation: Data not collected.
The normal limits of TUVjoint (on a per joint basis) in HC subjects, which are defined as the 5 and 95 percentiles of TUVjoint of bilateral joints (i.e., bilateral wrists, metacarpophalangeal joint \[MCPs\], proximal interphalangeal \[PIPs\]).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 39 daysPopulation: Data not collected.
Presence/absence of tilmanocept localization in the hands and wrists will be summarized with frequency counts and percentages by reader and joint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 39 daysPopulation: Data not collected.
Applicability of the Normal (Gaussian) distribution to TUVjoint data as assessed by normal quantile plots provided per joint and reader and p-value for the Shapiro-Wilk test of Normality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 39 daysPopulation: Data not collected.
Determination of joint-specific standardized uptake value (SUV) from SPECT/CT imaging within synovial spaces of the bilateral hands and wrists in HCs and RA subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 39 daysPopulation: Data not collected.
Assessment of the predictive value of planar scans for SPECT/CT scans.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 39 daysPopulation: The safety population was evaluated, which is any subject injected with Tc 99m tilmanocept.
Outcome measures
| Measure |
Primary Endpoint Arm 1 and 2. Secondary Endpoints Arm 1 and 2
n=120 Participants
Primary Endpoint Arm 1 The distribution of TUV joint in HC subjects were summarized with descriptive statistics: mean, standard deviation, n, minimum, maximum, and median per reader, joint, and view. The 5 and 95 percentiles will be estimated with quantile regression fitting an intercept as a fixed term. The lower and upper limits of normal TUV joint were determined using non-parametric confidence intervals and kernel density-based confidence intervals.
Primary Endpoint Arm 2 Localization of tilmanocept in the hands and wrists were summarized with frequency counts and percentages by reader and joint.
Secondary Endpoint Arm 1 Normal quantile plots were provided per joint and reader, along with the p-value for the Shapiro-Wilk test of normality.
Secondary Endpoints Arm 2 SUV was calculated and summarized on both a per-joint and a total of all joints with summary statistics: mean, standard deviation, n, minimum, maximum, and median.
The predictive value of planar scans for SPECT/CT qualitative findings was summarized per joint and reader with a crosstabulation and the uncertainty coefficients for row \| column, column \| row, and symmetric. The planar result was deemed to be "positive" (i.e., inflamed) if TUV joint \> 95 percentile of the reader results for the same joint in Arm 1. Otherwise, the planar result was deemed to be "negative."
|
Healthy Controls and RA Subjects on Stable Therapy
n=14 Participants
The second arm is comprised of \[1\] disease-free HCs and \[2\] clinically diagnosed RA subjects on stable treatment.
Tc99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|
|
Safety Objective: To Evaluate Safety Through the Examination of AE Incidence and Changes Over Time in Laboratory Tests, Vital Signs, and Physical Examination Findings.
Adverse Events
|
2 Participants
|
0 Participants
|
|
Safety Objective: To Evaluate Safety Through the Examination of AE Incidence and Changes Over Time in Laboratory Tests, Vital Signs, and Physical Examination Findings.
Abnormal Clinical Lab Results
|
1 Participants
|
0 Participants
|
|
Safety Objective: To Evaluate Safety Through the Examination of AE Incidence and Changes Over Time in Laboratory Tests, Vital Signs, and Physical Examination Findings.
Abnormal Vital Signs
|
2 Participants
|
0 Participants
|
|
Safety Objective: To Evaluate Safety Through the Examination of AE Incidence and Changes Over Time in Laboratory Tests, Vital Signs, and Physical Examination Findings.
Abnormal Physical Examinations
|
13 Participants
|
8 Participants
|
Adverse Events
Subjects Free of Inflammatory Disease
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy Controls and RA Subjects on Stable Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Free of Inflammatory Disease
n=120 participants at risk
Arm 1 includes HCs who are deemed to be clinically free of inflammatory diseases, arthropathies, and/or arthroplasties and clinically free of joint pain for at least 28 days prior to the consent date.
Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
Healthy Controls and RA Subjects on Stable Therapy
n=14 participants at risk
Arm 2 includes \[1\] disease-free HCs and \[2\] clinically diagnosed RA subjects on stable treatment.
Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.83%
1/120 • Number of events 1 • Untoward medical events beginning on Visit 2 (Day 0) through Visit 3 (Day 5 ± 3) were recorded as adverse events.
|
0.00%
0/14 • Untoward medical events beginning on Visit 2 (Day 0) through Visit 3 (Day 5 ± 3) were recorded as adverse events.
|
|
Nervous system disorders
Headache
|
0.83%
1/120 • Number of events 1 • Untoward medical events beginning on Visit 2 (Day 0) through Visit 3 (Day 5 ± 3) were recorded as adverse events.
|
0.00%
0/14 • Untoward medical events beginning on Visit 2 (Day 0) through Visit 3 (Day 5 ± 3) were recorded as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place