Clinical trial NCT04947137: Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
Official title: Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: RA
Healthy control
Tilmanocept
Lead sponsor: Navidea Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA. Subjects will be enrolled in 1 of 2 study arms with distinct study procedures in accordance with Arm-specific eligibility requirements.
Primary purpose: DIAGNOSTIC

Brief summary: This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.

Detailed description: This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA.

This study is stratified into 2 arms. Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment.

Eligibility criteria: 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. The subject has agreed to not engage in any diet, lifestyle, or medication changes until study completion.

   HEALTHY CONTROL SUBJECTS
3. The subject is 30 years of age or greater at the time of consent.
4. The subject is deemed to be clinically free of any inflammatory disease(s), autoimmune disease(s), or arthropathies and has not experienced joint pain for at least 28 days prior to the consent date.
5. The subject is not currently on anti-inflammatory drugs (including non-steroidal anti-inflammatory drugs \[NSAIDs\]) and has not taken any anti-inflammatories for at least 28 days prior to the consent date.
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 imaging visit (Day 0). 7. If the subject is receiving bDMARD or janus kinase (JAK) inhibitor therapy, they have been at a stable dose \> 60 days prior to the imaging visit (Day 0). 8. If the subject is receiving NSAIDs or oral corticosteroids, the dose has been stable for ≥ 28 days prior to the imaging visit (Day 0). The corticosteroid dose must be ≤ 10 mg/day of prednisone or an equivalent steroid dose.

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 is currently receiving radiation therapy or chemotherapy or has received radiation therapy or chemotherapy in the past six months.
4. The subject has had a finger, hand, and/or wrist amputation or hand or wrist joint arthroplasty.
5. The subject has renal insufficiency as demonstrated by a glomerular filtration rate of \< 60 mL/min.
6. The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase \[SGPT\]) or AST (aspartate aminotransferase \[SGOT\]) greater than 2 times the upper limit of normal.
7. The subject has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study participation or compromise the safety of the subject or the quality of the data.
8. The subject has any unstable medical illnesses, including hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
9. The subject has a known allergy to or has had an adverse reaction to dextran exposure.
10. The subject has received an investigational product within 30 days prior to Tc 99m tilmanocept administration (Day 0).
11. The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to Tc 99m tilmanocept administration (Day 0).
12. The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to Tc 99m tilmanocept administration (Day 0).
13. Healthy Controls only: The subject has a positive rheumatoid factor and an elevated ESR or CRP.

Primary outcomes:
measure: Normal Limits of TUVjoint in Healthy Subjects
timeFrame: Up to 39 days
measure: Qualitative Evaluation of SPECT/CT for Tilmanocept Localization
timeFrame: Up to 39 days
Secondary outcomes:
measure: Normal Distribution of TUVjoint
timeFrame: Up to 39 days
measure: Quantitative Evaluation of SPECT/CT
timeFrame: Up to 39 days
measure: Planar and SPECT/CT Comparison
timeFrame: Up to 39 days
Other outcomes:
measure: Safety Objective: To Evaluate Safety Through the Examination of AE Incidence and Changes Over Time in Laboratory Tests, Vital Signs, and Physical Examination Findings.
timeFrame: Up to 39 days
Locations:
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Webster
country: United States
facility: Tranquility Research
state: Texas
Study officials:
affiliation: Navidea Biopharmaceuticals
name: Michael Blue, MD
role: STUDY_DIRECTOR
References: