MyocarditisPhase 2NCT00004482
Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
A Phase 2 study testing Cyclosporine, methylprednisolone and Muromonab-CD3 in people with Myocarditis and Giant Cell Myocarditis, run by Mayo Clinic at 1 site in United States.
Trial summary
OBJECTIVES: I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis. II. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis, Giant Cell Myocarditis
- What is being tested?
- Cyclosporine, methylprednisolone and Muromonab-CD3
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jul 2006
- Phase
- Phase 2
- 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
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy
Heart failure and/or arrhythmia of less than 3 months duration
--Patient Characteristics--
Hepatic: AST/ALT no greater than 3 times upper limit of normal
Renal: Creatinine no greater than 2.5 mg/dL
Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to cyclosporine or muromonab-CD3; No other severe concurrent diseases
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVES:
- Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis.
II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms.
III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.
Read the detailed description
PROTOCOL OUTLINE:
This is a randomized, open label, multicenter study.
Patients are randomized to receive standard care with immunosuppression (arm I) or standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine)(arm II).
Arm I: Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days. Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year.
Arm II: Patients receive standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine).
Patients are followed for one year.
- Conditions
- Myocarditis, Giant Cell Myocarditis
- Being tested
- Cyclosporine, methylprednisolone, Muromonab-CD3, prednisone
- Keywords
- cardiovascular and respiratory diseases, giant cell myocarditis, rare disease
- Medical subject headings
- Myocarditis, Respiratory Tract Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
Muromonab-CD3Drug
prednisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1999
- Primary completionJul 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Leslie T. Cooper, Jr., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004482
- Sponsor's protocol ID
- 199/14209
- Other IDs
- MAYOC-1479901, MAYOC-1479900
- Status last verified
- Sep 2010
- First submitted
- 18 Oct 1999
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
- ClinicalTrials.gov ID
- NCT00004482
- Acronym / sponsor ID
- 199/14209
- Conditions
- Myocarditis, Giant Cell Myocarditis
- Keywords
- cardiovascular and respiratory diseases, giant cell myocarditis, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
- Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis.
II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms.
III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.
Detailed description
PROTOCOL OUTLINE:
This is a randomized, open label, multicenter study.
Patients are randomized to receive standard care with immunosuppression (arm I) or standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine)(arm II).
Arm I: Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days. Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year.
Arm II: Patients receive standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine).
Patients are followed for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cyclosporine | Drug | – |
| methylprednisolone | Drug | – |
| Muromonab-CD3 | Drug | – |
| prednisone | Drug | – |
Primary outcome
Not reported in the source record.
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 9 Sep 2010.
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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.
Leslie T. Cooper, Jr. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine, methylprednisolone and Muromonab-CD3 in people with Myocarditis and Giant Cell Myocarditis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 9 Sep 2010.