Pilot Study at Mayo Enrolling Patients

Dr. Fernando Fervenza of the Mayo Clinic Nephrology Collaborative Group (MNCG), along with co-investigator Dr. Ulrich Specks, announce a new pilot study on the use of Rituximab in the treatment of Churg Strauss Syndrome with renal involvement. The plan is to enroll five patients in the open label study using 4 weekly doses or Rituximab in the treatment of CSS with renal involvement. Patients will be followed for 1 year after beginning of the remission induction regimen. Disease relapses, as defined in the protocol will be treated according to the standard of practice for patients with this disease.

The MNCG flyer gives the rationale for the study:

"Churg-Strauss Syndrome (CSS) has many pathologic similarities with ANCA-associated vasculitis, which has recently been treated successfully with Rituximab. This Pilot Study will evaluate the effect of Rituximab in patients with Churg-Strauss syndrome and renal disease. Renal disease will be defined as either present on renal biopsy or by active urinary sediment including dysmorphic red cells and/or red cell casts. The endpoint for this particular trial will be resolution of the disease defined by the Birmingham Vasculitis Activity Score (VAS). The pilot nature of this study is a design feasible given the rarity of this syndrome (CSS). If life threatening disease progression occurs or no improvement can be achieved after two months, patient will be considered treatment failure and will be removed from the study and treated according to the best standard of care for the disease. Disease relapses that occurred before 16 weeks will also be considered treatment failures.

Rituximab is a genetically engineered monoclonal antibody directed against the CD20 antigen found on the surface of normal B cells. Rituximab has also been studied in a variety of autoimmune disorders where B cells and autoantibodies appear to play a role in pathophysiology. Rituximab has been reported to relieve signs and symptoms of rheumatoid arthritis, lupus, immune thrombocytopenia, autoimmune anemia, and
vasculitis."

The costs of medical tests and medications will be covered by the study. Patients will need to travel to Rochester, Minnesota to enroll and to receive treatment with Rituximab. However, please do not assume that you are ineligible for the study if you live far from the Mayo Clinic. Because Churg Strauss Syndrome is so rare and because CSS with renal involvement is rarer still, study coordinators may work with patients who live far away to find creative solutions to being able to participate in the study.

To learn more about this important study, including eligibility requirements, please contact MNCG@mayo.edu or call one of the study coordinators, Lori Riess at 507-266-1047 or Shirley Jennison at 507-255-0231.

The Mayo Clinic has good information about Churg Strauss Syndrome at their website.