Warm autoimmune haemolytic anemia (wAIHA)

People with Warm Autoimmune Hemolytic Anemia are asked to participate in a research study being conducted by North Shore University Hospital.

You may be eligible to participate in this study if you:
Double-blind Inclusion Criteria:
• Are a male or female at least 18 years of age
• Are diagnosed with active primary or secondary wAIHA
• Have a negative QuantiFERON®-TB Gold test
• Have an autoimmune disease
• Have sufficient venous access to allow drug administration by IV infusion and blood sampling
Open-label Inclusion Criteria:
• Have completed the double-blind period without discontinuing study drug for reasons other than the need for rescue therapy
• Have had no major eligibility deviations or other major protocol deviations during the double-blind period

You may NOT participate in this study if you:

Double-blind Exclusion Criteria
• Have received rituximab within 6 months
• Have a severe or chronic infection
• Have received a live vaccine 3 months prior to screening
• Have known immunodeficiency virus (HIV) infection, hepatitis B or C
• Have had major surgery 3 months prior to screening
• Are pregnant or breastfeeding

Open-label Exclusion Criteria:
• Currently have a serious or clinically significant infection
• Met any of the stopping criteria or discontinued study drug during the double-blind period due to AE

Contact Information
Carolyn Pellizzari, Study Coordinator
450 Lakeville Road, Lake Success, New York 11042
Phone: (516) 734-8921
Email: cpellizzar@northwell.edu