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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01134432
• Date of registration: 28/05/2010
• Prospective Registration: No
• Primary sponsor: Copenhagen University Hospital at Herlev
• Public title: Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
• Scientific title: Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.
• Date of first enrolment: March 2005
• Target sample size: 65
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01134432
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Denmark

Contacts

• Name: Henrik S Birgens, MD
• Affiliation: Department of Haematology (L121), Copenhagen University Hospital Herlev

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 years or over

- Clinical and biochemical signs of haemolytic anaemia

- Positive Coombs test with anti-IgG on its own or with anti-CD3d

- Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen
deposit) for women of childbearing potential

Exclusion Criteria:

- Performance status > 2

- Previous treatment with Rituximab

- Other immune suppressive or anti neoplastic treatment including prednisolone within 3
months

- Auto immune haemolytic anaemia within 6 months

- Other serious disease

- Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for
the duration of the study.

- Contraindication for treatment with Rituximab, i.e. patients that develop
hypersensitivity/allergy to the contents of the drug or have antibodies against
murine proteins.

- Active infection which requires antibiotic treatment



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia, Hemolytic, Autoimmune

Intervention(s)

Drug: prednisolone + mabthera

Drug: Prednisolone

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

AIHA-KA04062-gms

Source(s) of Monetary Support

Please refer to primary and secondary sponsors