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Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study Two


- candidate number4144
- NTR NumberNTR1469
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2008
- Secondary IDsCAMMS324 ClinicalTrials.gov NCT00548405
- Public TitleComparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study Two
- Scientific TitleA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed on Therapy
- ACRONYMCARE-MS II
- hypothesisThe purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months.
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS), Relapse, Alemtuzumab
- Inclusion criteria1. Age 18 - 55 years old 2. Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS 3. Onset of MS symptoms within 10 years 4. EDSS score 0.0 to 5.0 5. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months 6. Greater than or equal to 1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after being on that therapy for at least 6 months within 10 years.
- Exclusion criteria1. Previous treatment with alemtuzumab 2. Previous treatment with any investigational drug (i.e. medication that is not approved at any dose or for any indication) 3. Treatment with natalizumab, methotrexate, azothioprine or cyclosporine in the past 6 months 4. Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressive or cytotoxic therapy (other than steroid treatment) 5. Any progressive form of MS 6. Any progressive form of MS 7. Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS 8. Major systemic disease that cannot be treated or adequately controlled by therapy 9. Active infection or high risk for infection 10. Autoimmune disorder (other than MS) 11. Impaired hepatic or renal function 12. History of malignancy, except basal skin cell carcinoma 13. Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 14. Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating 15. Current participation in another clinical study or previous participation in CAMMS323 16. Previous hypersensitivity reaction to any immunoglobulin product 17. Known allergy or intolerance to interferon beta, human albumin, or mannitol 18. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis 19. Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver 20. Inability to undergo MRI with gadolinium administration 21. Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-okt-2007
- planned closingdate1-apr-2012
- Target number of participants700
- InterventionsExperimental intervention 1: alemtuzumab: 12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12 Experimental intervention 2: alemtuzumab: 24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12 (Note: The 24 mg alemtuzumab dose is closed to enrollment.) Active Comparator: interferon beta-1a (Rebif): 44 mcg administered 3-times weekly by SC injections for at least 2 years.
- Primary outcome- Time to Sustained Accumulation of Disability (SAD) [Time Frame: 2 years]
- Relapse Rate [Time Frame: 2 years] (Rater-blinding of efficacy outcomes)
- Secondary outcome- Proportion of patients who are relapse free at Year 2 [Time Frame: 2 years]
- Change from baseline in EDSS [Time Frame: 2 years]
- Acquisition of disability as measured by change from baseline in MSFC [Time Frame: 2 years]
- Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2 [Time Frame: 2 years]
(Rater-blinding of efficacy outcomes)
- Timepoints2 years
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Genzyme Europe B.V.
- CONTACT for SCIENTIFIC QUERIES Genzyme Europe B.V.
- Sponsor/Initiator Genzyme Corporation
- Funding
(Source(s) of Monetary or Material Support)
Genzyme Corporation, Bayer Schering Pharma B.V.
- Publications- Coles AJ, Cox A, Le Page E, et al. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006;253(1);98-108.


- Fox E, Sullivan H, Gazda S. Open label, single-arm, Phase II study of alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta-interferon therapies. Poster presentation P06.07 at the 59th Annual Meeting of the American Academy of Neurology (AAN) on 03 May 2007

- CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801.
- Brief summaryThe purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months. Every patient will receive active treatment; there is no placebo. The 24 mg alemtuzumab dose is closed to enrollment so newly enrolled patients will be randomly assigned to treatment with either 12 mg alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given 12 mg alemtuzumab for every 1 given Rebif®). Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif® will be self-injected 3 times per week for as long as the study continues. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, all patients who receive alemtuzumab will be followed in an extension study for safety and efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.
- Main changes (audit trail)29-06-09: Updates of the trialinformation (the following data is the original version).

Inclusion criteria:
1. Age 18 - 50 years old
2. Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS
3. Onset of MS symptoms within 5 years of screening
4. EDSS score 0.0 to 5.0
5. Greater than or equal to 2 MS attacks (first episode or relapses) occurring in the 2 years prior to screening, with greater than or equal to 1 attack in the 1 year prior to screening
6. Greater than or equal to 6 months continuous treatment with beta interferon or glatiramer acetate during the past 5 years prior to screening
7. Greater than or equal to 1 MS attack (relapse) while receiving treatment with interferon beta or glatiramer acetate after being on that therapy for at least 6 months.


Exclusion criteria:
1. Previous treatment with alemtuzumab or any other investigational drug for MS
2. Previous treatment with mitoxantrone or natalizumab
3. Exposure to immunosuppressive agents other than systemic corticosteroid treatment
4. Received treatment with a monoclonal antibody for any reason
5. Has any progressive form of MS
6. Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
7. Major systemic disease that cannot be treated or adequately controlled by therapy
8. Chronic infection with viral, mycobacterial or parasitic organisms
9. Autoimmune disorder (other than MS)
10. Impaired hepatic or renal function
11. History of malignancy (exception for basal cell skin carcinoma if disease-free for greater than or equal to 5 years)
12. Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
13. Of childbearing potential with a positive serum pregnancy test
14. Current participation in another clinical study or previous participation in CAMMS323
15. Previous hypersensitivity reaction to other immunoglobulin product
16. Known allergy or intolerance to interferon beta, human albumin, or mannitol
17. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
18. Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver
19. Inability to undergo MRI with gadolinium administration
20. Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only).


Target sample size: 1200.


Interventions:
Experimental intervention 1:
alemtuzumab: 12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12

Experimental intervention 2:
alemtuzumab: 24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12

Active Comparator: interferon beta-1a (Rebif): 44 mcg administered 3-times weekly by SC injections for at least 2 years.
- RECORD29-sep-2008 - 27-aug-2009


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