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 个研究点目标入组 22 人开始时间: 2012年4月3日最近更新: 2023年9月4日

试验速览

暂无简介。

•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

•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.

发起方

F. Hoffmann La Roche Ltd / Genentech Inc,