A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO
- Conditions
- Primary Progressive Multiple Sclerosis (PPMS)MedDRA version: 9.1Level: LLTClassification code 10063401
- Registration Number
- EUCTR2010-020338-25-IT
- 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
- 650
1. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments; 2. Diagnosis of PPMS in accordance with the revised McDonald criteria (2005); 3. Ages 18-50 years inclusive; 4. EDSS at screening from 3.0 to 6.5 points; 5. Score of = 2.0 on the Functional Systems (FS) scale for the pyramidal system that is due to lower extremity findings; 6. Disease duration from the onset of MS symptoms: a. less than 15 years in patients with an EDSS at screening > 5.0 b. less than 10 years in patients with an EDSS at screening = 5.0; 7. Documented history or presence at screening of at least one of the following laboratory findings in a CSF specimen [source documentation of laboratory results and method must be verified]: a. elevated IgG index b. one or more IgG oligoclonal bands detected by isoelectric focusing 8. For sexually active female and male patients of reproductive potential, use of reliable means of contraception as described below as a minimum (adherence to local requirements, if more stringent, is required*): • Two methods of contraception throughout the trial, including the active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or until their B-cells have repleted, whichever is longer. Acceptable methods of contraception include one primary (e.g. systemic hormonal contraception or tubal ligation of the female partner, vasectomy of the male partner) AND one secondary barrier method (e.g. latex condoms, spermicide) OR a double barrier method (e.g. latex condom, intrauterine device, vaginal ring or pessary plus spermicide (e.g. foam, vaginal suppository, gel, cream)); 9. For patients of non reproductive potential (adherence to local requirements,if more stringent, is required*): • Women may be enrolled if postmenopausal (i.e. spontaneous amenorrhea for the past year confirmed by an FSH level greater than 40 mIU/mL) unless the patient is receiving a hormonal therapy for theirmenopause or surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy); • Men may be enrolled if they are surgically sterile (castration). * Based on local Ethics Committees or National Competent Authority feedback additional requirements to assure contraception or to confirm menopause may be required (e.g. serum estradiol compatible with post-menopause status, longer duration of amenorrhea, higher level of FSH).
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
Patients who meet the following criteria will be excluded from study entry: 1. History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening; 2. Inability to complete an MRI (contraindications for MRI include but are not restricted to known allergy to gadolinium contrast dyes, renal impairment which would contraindicate gadolinium injection, claustrophobia, weight = 140 kg, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.); 3. Contraindications for or intolerance to oral or i.v. corticosteroids, including methylprednisolone administered i.v., according to the country label, including: a. Psychosis not yet controlled by a treatment; b. Hypersensitivity to any of the constituents; 4. Known presence of other neurologic disorders, including but not limited to, the following: a. History of ischemic cerebrovascular disorders (e.g. stroke, transient ischemic attack) or ischemia of the spinal cord; b. History or known presence of CNS or spinal cord tumor (e.g. meningioma, glioma); c. History or known presence of potential metabolic causes of myelopathy (e.g. untreated vitamin B12 deficiency); d. History or known presence of infectious causes of myelopathy (e.g. syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy); e. History of genetically inherited progressive CNS degenerative disorder (e.g. hereditary paraparesis; MELAS [mitochondrial myopathy, encephalopathy, lactic acidosis, stroke] syndrome); f. Neuromyelitis optica; g. History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, antiphospholipid antibody syndrome, Sj?gren’s syndrome, Beh?et’s disease); h. History or known presence of sarcoidosis; i. History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression); j. History of PML. Et al...
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