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

Inclusion Criteria:

1. The subject has provided written informed consent with HIPAA (Health InformationPortability and Accountability Act) authorization before the initiation of anystudy-related procedures.

2. The subject is at least 18 years of age and was ≥ 18 years of age at the time of RAdiagnosis.

3. The subject is a candidate for initiation of, or change to, a new anti-TNFα bDMARDtherapy.

4. The subject has RA as determined by the 2010 American College ofRheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score of ≥ 6/10).

5. The subject has moderate to severe RA as determined by a 28-joint disease activityscore (DAS28) of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test andVisual Analog Scale [VAS]).

6. Subjects receiving traditional DMARDs must have been on therapy for ≥ 90 days and ata stable dose for ≥ 30 days prior to the first imaging visit (Day 0).

7. Subjects receiving bDMARD or janus kinase (JAK) inhibitor therapy must have been ata stable dose > 60 days prior to the first imaging visit (Day 0).

8. If the subject is receiving NSAIDS (nonsteroidal anti-inflammatory drug) or oralcorticosteroids, the dose has been stable for > 28 days prior to the first imagingvisit (Day 0). The corticosteroid dose must be ≤ 10 mg/day of prednisone or anequivalent 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 receivedradiation or chemotherapy within the past 5 years.

4. The subject has an active malignancy or a history of malignancy within the past 5years.

5. The subject has had a finger, hand, and/or wrist amputation or hand or wrist jointarthroplasty.

6. The subject has renal insufficiency as demonstrated by a glomerular filtration rateof < 60 mL/min.

7. The subject has hepatic insufficiency as demonstrated by ALT (alanineaminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 2times the upper limit of normal.

8. The subject has any severe, acute, or chronic medical conditions and/or psychiatricconditions and/or laboratory abnormalities that would impart, in the judgment of theinvestigator, excess risk associated with study participation or study drugadministration that would deem the subject inappropriate for study participation.

9. The subject has a history of hypersensitivity reactions to TNF-inhibitors.

10. The subject has a known allergy to or has had an adverse reaction to dextranexposure.

11. The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration at the first imaging visit (Day 0).

12. The subject has received intra-articular corticosteroid injections ≤ 8 weeks priorto the first imaging visit (Day 0).

13. The subject has received any radiopharmaceutical within 7 days or 10 half-livesprior to the administration of Tc 99m tilmanocept at the first imaging visit (Day 0).

14. The subject has heart failure [New York Heart Association (NYHA) Class III-IV], ademyelinating disorder, or a chronic/latent infection [e.g., +Purified ProteinDerivative (PPD) test, Human Immunodeficiency Virus (HIV), Hepatitis B].