Trial Outcomes & Findings for Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA (NCT NCT05246280)

NCT ID: NCT05246280

Last Updated: 2025-01-23

Results Overview

Specificity of the change in TUVglobal with bucketing from baseline to 5 weeks after a change in anti-TNFα therapy (ΔTUVglobal\[5w\] with bucketing) with respect to ACR50 at week 24 after the change in therapy.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

169 participants

Primary outcome timeframe

Up to 213 days

Results posted on

2025-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Overall Study STARTED	169
Overall Study COMPLETED	169
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy n=169 Participants All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	128 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants
Age, Continuous	59.2 years n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	169 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

Specificity of the change in TUVglobal with bucketing from baseline to 5 weeks after a change in anti-TNFα therapy (ΔTUVglobal\[5w\] with bucketing) with respect to ACR50 at week 24 after the change in therapy.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

Sensitivity of the change in TUVglobal with bucketing from baseline to 5 weeks after change in anti-TNFα therapy (ΔTUVglobal\[5w\] with bucketing) with respect to ACR50 at week 24 after the change in therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

NPV of TUV global obtained at baseline (TUVglobal\[b\]) with respect to ACR50 at week 24 after change in anti-TNFα therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

Concordance of ΔTUVglobal\[5w\] with bucketing and ACR50 at week 12, evaluated using sensitivity and specificity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 213 days

Population: Data not collected.

Concordance of ΔTUVglobal\[5w\] (with bucketing) and clinical criteria, including ACR Response Criteria, CDAI, DAS28, and HAQ-DI©. Concordance between ΔTUVglobal\[5w\] and the clinical criteria will be evaluated using NPV, PPV and overall accuracy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 213 days

Population: Data not collected.

Negative predictive value (NPV) of TUVglobal obtained at baseline (TUVglobal\[b\]) with respect to ACR50 at week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

TUVglobal\[b\] 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, by the CFB of DAS28 to 12 +/- 1 weeks and 24 +/- 1 weeks and by the CFB in each of the ACR Response Criteria components at 12 +/- 1 weeks and at 24 +/- 1 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

ΔTUVglobal\[5w\] and response to new anti-TNFα bDMARD therapy defined by the CFB of CDAI to 12 +/- 1 weeks and 24 +/- 1 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

Concordance of ΔTUVglobal\[5w\] (without bucketing) and clinical criteria, including ACR Response Criteria, CDAI, DAS28, and HAQ-DI©. Concordance between ΔTUVglobal\[5w\] and the clinical criteria will be evaluated using NPV, PPV, sensitivity, specificity, and overall accuracy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

Concordance of ΔTUVglobal\[12w\] and change in clinical criteria, including ACR Response Criteria, CDAI, DAS28, and HAQ-DI©. Concordance between ΔTUVglobal\[12w\] and the clinical criteria will be evaluated using NPV, PPV, sensitivity, specificity, and overall accuracy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: Data not collected.

Correlation of ΔTUVglobal\[5w\] and response to new anti-TNFα bDMARD therapy from baseline to 24 +/- 1 weeks defined by the changes from baseline in each of the ACR Response Criteria components, including: * Tender joint count (TJC) * Swollen joint count (SJC) * Patient assessment of global disease activity * Rheumatologist assessment of global disease activity * Patient assessment of pain * Patient assessment of physical function * Acute-phase reactant value

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 213 days

Population: All subjects injected with Tc 99m tilmanocept were evaluated.

Incidence of AEs related to Tc 99m tilmanocept.

Outcome measures

Outcome measures
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy n=169 Participants All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs Adverse Events Severity - Mild	47 Adverse Events
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs Adverse Events Severity - Moderate	84 Adverse Events
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs Adverse Events Severity - Severe	1 Adverse Events
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs Adverse Events Relatedness - Possibly Related	1 Adverse Events
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs Adverse Events Relatedness - Probably Not Related	1 Adverse Events
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by AEs Adverse Events Relatedness - Definitely Not Related	130 Adverse Events

SECONDARY outcome

Timeframe: Up to 213 days

Population: All subjects injected with Tc 99m tilmanocept were evaluated.

Number of participants with changes over time in clinical laboratory tests (hematology, serum chemistry, urinalysis, and RA panel).

Outcome measures

Outcome measures
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy n=169 Participants All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in Clinical Laboratory Tests	2 Participants

SECONDARY outcome

Timeframe: Up to 213 days

Population: All subjects injected with Tc 99m tilmanocept were evaluated.

Number of participants with changes over time in ECG parameters (PRS Interval, QRS Duration, QT Interval, and QTc Interval).

Outcome measures

Outcome measures
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy n=169 Participants All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in ECG Parameters	2 participants

SECONDARY outcome

Timeframe: Up to 213 days

Population: All subjects injected with Tc 99m tilmanocept were evaluated.

Number of participants with changes over time in vital signs (blood pressure, heart rate, respiratory rate, and temperature).

Outcome measures

Outcome measures
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy n=169 Participants All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Safety of IV-administered Tilmanocept Radiolabled With Tc 99m Assessed by Number of Participants With Changes Over Time in Vital Signs	9 participants

Adverse Events

Candidates for Initiation of Anti-TNFα bDMARD Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Candidates for Initiation of Anti-TNFα bDMARD Therapy n=169 participants at risk All subjects will be candidates for initiation of, or change to, a new anti-TNFα bDMARD for RA treatment. TC99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Skin and subcutaneous tissue disorders scalp laceration	0.59% 1/169 • Number of events 1 • Up to 213 days.
Social circumstances Blunt abdominal trauma	0.59% 1/169 • Number of events 1 • Up to 213 days.
Cardiac disorders snycope	0.59% 1/169 • Number of events 1 • Up to 213 days.
General disorders acute appendicitis	0.59% 1/169 • Number of events 1 • Up to 213 days.
Cardiac disorders Non-Cardiac Atypical Chest Pain	0.59% 1/169 • Number of events 1 • Up to 213 days.

Other adverse events

Adverse event data not reported

Additional Information

Michael Blue, MD

Navidea Biopharmaceuticals

Phone: 6145714313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clinical Trial Agreement states that no publications will be made unless approval by the sponsor is granted.
Publication restrictions are in place

Restriction type: OTHER