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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01134432
First received: May 28, 2010
Last updated: September 9, 2013
Last verified: September 2013

May 28, 2010
September 9, 2013
March 2005
July 2012   (final data collection date for primary outcome measure)
Number of patients in each group in complete or partial remission [ Time Frame: End of treatment and follow-up for 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01134432 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: End of treatment plus follow-up for 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia, Hemolytic, Autoimmune
  • 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
  • Drug: Prednisolone
    Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months
  • Experimental: Prednisolone + Rituximab
    Intervention: Drug: prednisolone + mabthera
  • Active Comparator: Prednisolone
    Intervention: Drug: Prednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01134432
AIHA-KA04062-gms
No
Copenhagen University Hospital at Herlev
Copenhagen University Hospital at Herlev
Not Provided
Principal Investigator: Henrik S Birgens, MD Department of Haematology (L121), Copenhagen University Hospital Herlev
Copenhagen University Hospital at Herlev
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP