A DOSE-FREQUENCY BLINDED, MULTICENTER, EXTENSION STUDY TO DETERMINE THE LONG-TERM SAFETY AND EFFICACY OF PEGYLATED INTERFERON BETA-1A (BIIB017) IN SUBJECTS WITH RELAPSING MULTIPLE SCLEROSIS

Biogen Idec, Inc.,0 个研究点目标入组 20 人开始时间: 2011年7月25日最近更新: 2023年9月4日

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•1. ABILITY TO UNDERSTAND THE PURPOSE AND RISKS OF THE STUDY AND PROVIDE SIGNED AND DATED INFORMED CONSENT AND AUTHORIZATION TO USE PROTECTED HEALTH INFORMATION (PHI) IN ACCORDANCE WITH NATIONAL AND LOCAL SUBJECT PRIVACY REGULATIONS.
•2. SUBJECTS WHO PARTICIPATING IN STUDY 105MS301, WHO COMPLETED THE STUDY TREATMENT AND VISIT SCHEDULE THROUGH WEEK 96.
•3. SUBJECTS OF CHILDBEARING POTENTIAL MUST PRACTICE EFFECTIVE CONTRACEPTION DURING THE STUDY AND BE WILLING AND ABLE TO CONTINUE CONTRACEPTION FOR 3 MONTHS AFTER THEIR LAST DOSE OF STUDY TREATMENT. FOR FURTHER DETAILS OF CONTRACONCEPTIVE REQUIREMENTS FOR THIS STUDY, PLEASE REFER TO SECTION 15.5.3.

•1. SUBJECTS EXCEEDING MORE THAN 6 WEEKS SINCE COMPLETION OF THE WEEK 96 VISIT OF STUDY 105MS301.
•2. SUBJECTS WITH ANY SIGNIFICANT CHANGE IN MEDICAL HISTORY, INCLUDING LABORATORY TESTS, OR A CURRENT CLINICALLY SIGNIFICANT CONDITION THAT IN THE OPINION OF THE INVESTIGATOR WOULD HAVE EXCLUDED THE SUBJECT FROM PARTICIPATION IN STUDY 105MS301. THE INVESTIGATOR MUST RE-REVIEW THE SUBJECT´S MEDICAL FITNESS FOR PARTICIPATION AND CONSIDER ANY FACTORS THAT WOULD PRECLUDE TREATMENT INCLUDING:
•PRESENCE OF ANY CLINICALLY SIGNIFICANT (AS DETERMINED BY THE INVESTIGATOR) CARDIAC, ENDOCRINOLOGIC, HEMATOLOGIC, HEPATIC, IMMUNOLOGIC, METABOLIC, UROLOGIC, PULMONARY, NEUROLOGIC, DERMATOLOGIC, PSYCHIATRIC, RENAL, OR OTHER MAJOR DISEASE THAT WOULD PRECLUDE PARTICIPATION IN A CLINICAL STUDY.
•PRESENCE OF MALIGNANT DISEASE, INCLUDING SOLID TUMORS ND HEMATOLOGIC MALIGNANCIES (WITH THE EXCEPTION OF BASAL CELL AND SQUAMOUS CELL CARCINOMAS OF THE SKIN THAT HAVE BEEN COMPLETELY EXCESED AND ARE CONSIDERED CURED).
•CLINICALLY SIGNIFICANT LABORATORY ABNORMALITIES (HEMATOLOGY AND BLOOD CHEMISTRY) ON THE MOST RECENTLY AVAILABLE TEST OF STUDY 105MS301, AS DETERMINED BY THE INVESTIGATOR.

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