We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01134432
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : September 10, 2013
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

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.

Condition or disease Intervention/treatment Phase
Anemia, Hemolytic, Autoimmune Drug: prednisolone + mabthera Drug: Prednisolone Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.
Study Start Date : March 2005
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Prednisolone + Rituximab Drug: prednisolone + mabthera

Prednisolone: 1,5 mg/kg for two weeks with gradually reduced dosis over two months.

Mabthera: 375 mg/m2 once a week for four weeks

Other Name: mabthera equals Rituximab

Active Comparator: Prednisolone Drug: Prednisolone
Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134432

Layout table for location information
Aalborg Hospital
Aalborg, Denmark, DK-9000
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, DK-2100
Esbjerg Sygehus
Esbjerg, Denmark, DK-6700
Haderslev Sygehus
Haderslev, Denmark, DK-6100
Department of Haematology, Herlev Hospital
Herlev, Denmark, DK-2730
Holstebro Sygehus
Holstebro, Denmark, DK-7500
Naestved Sygehus
Naestved, Denmark, DK-4700
Odense University Hospital
Odense, Denmark, DK-5000
Roskilde Hospital
Roskilde, Denmark, DK-4000
Vejle Hospital
Vejle, Denmark, DK-7100
Viborg Sygehus
Viborg, Denmark, DK-8800
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Layout table for investigator information
Principal Investigator: Henrik S Birgens, MD Department of Haematology (L121), Copenhagen University Hospital Herlev
Layout table for additonal information
Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01134432    
Other Study ID Numbers: AIHA-KA04062-gms
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013
Keywords provided by Copenhagen University Hospital at Herlev:
autoimmune hemolytic anemia
hemolytic anemia
Treatment of autoimmune hemolytic anemia
warm antibody dependant autoimmune hemolytic anemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents