A Study of Ocrelizumab in Comparison With Interferon Beta-1a inPatients With Relapsing Multiple Sclerosis.

• Conditions: Relapsing Multiple Sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020337-99-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
2. Ages 18-55 years at screening, inclusive.
3. Diagnosis of MS, in accordance with the revised McDonald criteria (2010).
4. At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the year prior to screening (but not within
30 days prior to screening).
5. Neurological stability for = 30 days prior to both screening and baseline.
6. EDSS, at screening, from 0 to 5.5 inclusive.
7. Documented MRI of brain with abnormalities consistent with MS prior to screening.
8. Patients of reproductive potential must use 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 their
menopause 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of primary progressive MS.
2. Disease duration of more than 10 years in patients with an EDSS = 2.0 at
screening.
3. Inability to complete an MRI (contraindications for MRI include but are not restricted to claustrophobia, weight = 140 kg, pacemaker, cochlear
implants, presence of foreign substances in the eye, 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).
4. Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
Exclusions Related to General Health
5. Pregnancy or lactation.
6. Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
7. History or currently active primary or secondary immunodeficiency.
8. Lack of peripheral venous access.
9. History of severe allergic or anaphylactic reactions to humanized or
murine monoclonal antibodies.
10. Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study.
11. Congestive heart failure (NYHA III or IV functional severity).
12. Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds.
13. Infection requiring hospitalization or treatment with i.v. antibiotics within
4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit.
14. History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis).
15. History of progressive multifocal leukoencephalopathy (PML)
16. History of malignancy, including solid tumors and hematological
malignancies, except basal cell carcinoma, in situ squamous cell
carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins.
17. History of alcohol or drug abuse within 24 weeks prior to baseline.
18. History or laboratory evidence of coagulation disorders. Et al...

Study & Design

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