A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis
- Conditions
- Primary Progressive Multiple Sclerosis (PPMS)MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-020338-25-NL
- Lead Sponsor
- F.Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 732
• Adult patients, 18-55 years of age
• Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
• Expanded Disability Status Scale (EDSS) 3.0 to 6.5 points
• Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS = 5.0
• Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks for femails and 24 weeks for males after the last dose
Patients who meet the following entry criteria may participate in the OLE phase:
• Completed the Blinded Treatment Period of the trial and who, in the opinion of the Investigator, may benefit from treatment with ocrelizumab;
• Able and willing to provide written informed consent to participate in the OLE phase and to comply with the study protocol;
• Willing to continue to use at least two contraceptive methods
• Meet the re-treatment criteria with ocrelizumab
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 630
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
• Contraindications for Magnetic Resonance Imaging (MRI)
• Known presence of other neurologic disorders
• Known active infection or history of or presence of recurrent or chronic infection
• History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
• Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
• Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study;
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