Status:
WITHDRAWN
High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Johns Hopkins University
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if high-dose cyclophosphamide followed by a maintenance dose of glatiramer acetate is safe in patients with relapsing remitting multiple sclerosis (MS). The i...
Detailed Description
Multiple sclerosis (MS) is an autoimmune disease characterized by progressive immune-mediated destruction of myelin and axons within the CNS. Despite the development, approval and clinical utilization...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males and females between the ages of 18 and 70 years, inclusive.
- Diagnosis of clinically definite MS according to the McDonald Criteria.
- Must have been on conventional immunomodulatory treatment (interferon beta-1a, glatiramer acetate, or natalizumab) for at least 3 months OR have not tolerated conventional treatment OR have refused to start conventional treatment.
- 2 or more total gadolinium enhancing lesions on each of two pretreatment MRI scans at screening and enrollment.
- Subject must have EDSS ranging from 1.5 to 6.5.
- Subject must have had at least one clinical exacerbation in the last year and this must have occurred after having been on Avonex, Betaseron, Copaxone, Rebif or Natalizumab therapy for at least 3 months. This does not apply if subject has refused to start conventional therapy.
- Subject must have had a sustained (≥ 3 months) increase of \> 1.0 on the EDSS (historical estimate allowed) between 3.0 and 5.5 or \> 0.5 between 5.5 and 6.5 (while on therapy).
- Written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
- Women of childbearing potential should have a negative pregnancy test prior to entry into the study.
- Exclusion criteria
- Any risk of pregnancy--ALL female patients must have an effective means of birth control or be infertile due to hysterectomy, fallopian tube surgery, or premature menopause.
- Cardiac ejection fraction of \< 45%.
- Serum creatinine \> 2.0.
- Patients who are pre-terminal or moribund.
- Bilirubin \> 2.0, transaminases \> 2x normal.
- Patients with EDSS \< 3.0 or \> 6.5.
- Patients with pacemakers and implants who cannot get serial MRIs.
- Patients with active infections until infection is resolved.
- Patients with WBC count \< 3000 cells/µl, platelets \< 100,000 cells/µl and untransfused hemoglobin \< 10 g/dl.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00939549
Start Date
November 1 2010
End Date
November 1 2010
Last Update
September 26 2018
Active Locations (1)
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1
Johns Hopkins Hospital Multiple Sclerosis Center
Baltimore, Maryland, United States, 21287