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

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 or chemotherapy within the past 5 years.
• •4. The subject has an active malignancy or a history of malignancy within the past 5 years.
• •5. The subject has had a finger, hand, and/or wrist amputation or hand or wrist joint arthroplasty.
• •6. The subject has renal insufficiency as demonstrated by a glomerular filtration rate of \< 60 mL/min.
• •7. 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.
• •8. 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.
• •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 dextran exposure.
• •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 prior to the first imaging visit (Day 0).
• •13. The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept at the first imaging visit (Day 0).
• •14. The subject has heart failure \[New York Heart Association (NYHA) Class III-IV\], a demyelinating disorder, or a chronic/latent infection \[e.g., +Purified Protein Derivative (PPD) test, Human Immunodeficiency Virus (HIV), Hepatitis B\].