The 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…
ID
Bron
Verkorte titel
Aandoening
Multiple Sclerosis, Relapsing-Remitting
Ondersteuning
Bayer Schering Pharma AG
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Time to Sustained Accumulation of Disability (SAD) [Time Frame: 2 years] <br>
- Relapse Rate [Time Frame: 2 years]
(Rater-blinding of efficacy outcomes)
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
The 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.
Onderzoeksopzet
2 years
Onderzoeksproduct en/of interventie
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 (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.
Publiek
Gooimeer 10
Genzyme Europe B.V.
[default] 1411 DD
The Netherlands
eumedinfo@genzyme.com
Wetenschappelijk
Gooimeer 10
Genzyme Europe B.V.
[default] 1411 DD
The Netherlands
eumedinfo@genzyme.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1409 |
| NTR-old | NTR1469 |
| Ander register | ClinicalTrials.gov NCT00548405 : CAMMS324 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
<br><br>
- 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
<br><br>
- 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.