A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio

• Conditions: Primary Progressive Multiple Sclerosis (PPMS); MedDRA version: 15.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020338-25-DK
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-07
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

- Adult patients, 18-50 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 females and 24 weeks for males after the last dose
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified