A study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis.
- Conditions
- Relapsing Remitting Multiple SclerosisMedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2006-001161-42-DE
- Lead Sponsor
- Biogen Idec Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. Must give written informed consent and any authorizations required by local law
2. Must be 18 to 55 years of age, inclusive, at the time of informed consent.
3. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald
criteria #1-4
4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
5. Must meet either of the following 2 criteria:
a) Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to
obtain a current scan if a scan performed previously is available from the subject’s
history; if a scan is not available from the subject’s history, then the baseline scan
may be used). For inclusion purposes, a relapse is defined as neurologic signs and/or
symptoms documented by a neurologist in the medical record and of at least 24 hours duration to be determined by the Investigator or the Treating Neurologist. Time since relapse should be measured from the time of relapse onset, OR
b) Show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization (if scan is not available from the subject’s history,
then baseline scan may be used).
6.Must be disqualified from standard treatment for MS (sites in Poland and Germany only). Candidates in Poland must be from one of the following patient populations:
• Patients who rejected standard treatment for MS
• Patients with contraindications for using standard treatment for MS
• Patients for whom standard treatment for MS has proven ineffective
• Patients who are on the waiting list for state-funded treatment for MS, but who will not receive standard treatment for the duration of the study (15 months)
Candidates in Germany must be from one of the following patient populations:
• Patients who rejected standard treatment for MS,
• Patients with contraindications for using standard treatment for MS,
• Patients for whom standard treatment for MS has proven ineffective.
7. Male subjects and female subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue
contraception for 4 months after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
2. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous sell carcinomas are eligible to participate in this study.
3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
4. History of abnormal laboratory results that, in the opinion of the investigator, are
indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic,
psychiatric, renal, neurologic (other than MS), and/or other major disease that would preclude administration of DAC HYP.
5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.
6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
8. Positive for hepatitis C virus (HCV) antibody and/or positive for hepatitis B surface
antigen (HBsAg) at Screening.
9. Signs of silent infection with tuberculosis, including a positive TB screening test (German sites only)
10.Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening.
11. Exposure to varicella zoster virus within 21 days before Screening.
12. Any of the following abnormal blood tests at Screening:
• Hemoglobin =9.0 g/dL
• Platelets =100 × 109/L
• Lymphocytes =1.0 × 109/L
• Neutrophils =1.5 × 109/L
• Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 x the upper limit of normal (ULN)
• Serum creatinine >ULN
13. Any previous treatment with daclizumab or Zenapax®
14. Any of the following types of live virus vaccine from 4 weeks before randomization:
measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and
nasal influenza vaccine. Use of these vaccines, however, by other members of the
subject’s household does not affect the eligibility of patients to enroll or continue in the study.
15. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV)
antibiotics within 8 weeks before randomization.
16. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study.
17. Prior treatment with the any of the following:
• total lymphoid irradiation
• cladribine
• mitoxantrone
• T-cell or T-cell receptor vaccination
• any therapeutic monoclonal antibody, except natalizumab or rituximab
18. Prior treatment with cyclophosphamide or rituximab within 1 year prior to
randomization.
19. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:
• natalizumab
• cyclosporine
• azathioprine
• methotrexate
• intravenous immunoglobulin (IVIg)
• plasmapheresis or cytapheresis
20. Prior treatment with any of the following within the 3 months prior to randomization:
• SC or oral glatiramer acetate
• IFN-alpha
• IFN-beta (subjects who are positive for neutralizing antibodies to IFN-beta may
receive IFN-beta treatment up to 2 weeks prior to randomization)
21. Treatment with any of the following medications within the 30 days prior to
randomization:
• IV co
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method