Clinical Trial: Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.

Brief Summary: The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will recur after end of treatment or during the gradual reduction in dose of the drug. As a result, many patients will finally be splenectomized or be treated with long-term glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent studies have shown however, that some patients will respond to treatment with the chimeric anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the studies, Rituximab has been used in refractory disease or at least as second line treatment. In this study, patients with AIHA are randomized to receive either high-dose prednisolone with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375 mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of the patients in the two treatment arms. The primary treatment goal is a reduction in the number of patients who obtain long-term complete or partial remission. The secondary treatment goal is a reduction in patients who will be splenectomised or receive other immunosuppressive drugs. Finally a comparison of side effects of the treatments will take place.

Detailed Summary:
Sponsor: Copenhagen University Hospital at Herlev

Current Primary Outcome: Number of patients in each group in complete or partial remission [ Time Frame: End of treatment and follow-up for 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Side effects [ Time Frame: End of treatment plus follow-up for 12 months ]

Original Secondary Outcome: Same as current

Information By: Copenhagen University Hospital at Herlev

Dates:
Date Received: May 28, 2010
Date Started: March 2005
Date Completion:
Last Updated: September 9, 2013
Last Verified: September 2013