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Clinical Trials/PER-128-11
PER-128-11
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A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMPARISON TO INTERFERON BETA-1A (REBIF®) IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS

F. Hoffmann La Roche Ltd / Genentech Inc,0 sites22 target enrollmentApril 3, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
F. Hoffmann La Roche Ltd / Genentech Inc,
Enrollment
22
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 3, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
F. Hoffmann La Roche Ltd / Genentech Inc,

Eligibility Criteria

Inclusion Criteria

  • •1\. ABILITY TO PROVIDE WRITTEN, INFORMED CONSENT AND TO BE COMPLIANT WITH THE SCHEDULE OF PROTOCOL ASSESSMENTS.
  • •2\. AGE 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, 0 to 5\.5 INCLUSIVE.
  • •7\. DOCUMENTED MRI OF BRAIN WITH ABNORMALITIES CONSITENT WITH MS PRIOR THE SCREENING.
  • •8\. PATIENTS OF REPRODUCTIVE POTENTIAL MUST USE RELIABLE MEANS OF CONTRACEPCTION 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 AN 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

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 CLAUSTROFOBIA, WEIGHT ≥ 140 KG, PACEMAKER, COCHLEAR IMPLANTS, PRESENCE OF FOREIGN SUBTANCES 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 DOSORDERS.
  • •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.

Outcomes

Primary Outcomes

Not specified

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