Anemia, Hemolytic, AutoimmunePhase 3NCT01134432
Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
A Phase 3 study testing prednisolone + mabthera and Prednisolone in people with Anemia, Hemolytic, Autoimmune, run by Copenhagen University Hospital at Herlev at 11 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Hemolytic, Autoimmune
- What is being tested?
- prednisolone + mabthera and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 11 sitesDenmark
- Study dates
- Mar 2005to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Denmark11 sites
Aalborg Hospital
Aalborg, DK-9000
Rigshospitalet - Copenhagen University Hospital
Copenhagen, DK-2100
Esbjerg Sygehus
Esbjerg, DK-6700
Haderslev Sygehus
Haderslev, DK-6100
Department of Haematology, Herlev Hospital
Herlev, DK-2730
Holstebro Sygehus
Holstebro, DK-7500
Naestved Sygehus
Næstved, DK-4700
Odense University Hospital
Odense, DK-5000
Roskilde Hospital
Roskilde, DK-4000
Vejle Hospital
Vejle, DK-7100
Viborg Sygehus
Viborg, DK-8800
About this study
Official title: 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.
- Conditions
- Anemia, Hemolytic, Autoimmune
- Being tested
- prednisolone + mabthera, Prednisolone
- Keywords
- autoimmune hemolytic anemia, hemolytic anemia, Rituximab, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia
- Medical subject headings
- Anemia, Hemolytic, Autoimmune, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisolone + mabtheraDrug
Also called mabthera equals Rituximab
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
PrednisoloneDrug
Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone + Rituximab | Experimental | Not described Receives: Drug: prednisolone + mabthera |
| Prednisolone | Active comparator | Not described Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in each group in complete or partial remission
Measured: End of treatment and follow-up for 12 months
Secondary outcomes (1)
Side effects
Measured: End of treatment plus follow-up for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMar 2005
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Hemolytic, AutoimmuneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik S Birgens, MD, Principal investigator, Department of Haematology (L121), Copenhagen University Hospital Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134432
- Sponsor's protocol ID
- AIHA-KA04062-gms
- Status last verified
- Sep 2013
- First submitted
- 28 May 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.
- ClinicalTrials.gov ID
- NCT01134432
- Acronym / sponsor ID
- AIHA-KA04062-gms
- Conditions
- Anemia, Hemolytic, Autoimmune
- Keywords
- autoimmune hemolytic anemia, hemolytic anemia, Rituximab, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone + Rituximab | Experimental | Drug: prednisolone + mabthera |
| Prednisolone | Active comparator | Drug: Prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisolone + mabtheraAlso: mabthera equals RituximabPrednisolone: 1,5 mg/kg for two weeks with gradually reduced dosis over two months. Mabthera: 375 mg/m2 once a week for four weeks | Drug | Prednisolone + Rituximab |
| PrednisolonePrednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months | Drug | Prednisolone |
Primary outcome
Number of patients in each group in complete or partial remission
Time frame: End of treatment and follow-up for 12 months
1 secondary outcome
Side effects
Time frame: End of treatment plus follow-up for 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik S Birgens, MD principal investigator
Department of Haematology (L121), Copenhagen University Hospital Herlev
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prednisolone + mabthera and Prednisolone in people with Anemia, Hemolytic, Autoimmune, run by Copenhagen University Hospital at Herlev at 11 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.