A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).

Biogen Idec GmbH0 个研究点目标入组 1,050 人开始时间: 2005年1月13日最近更新: 2013年4月22日

适应症

试验速览

暂无简介。

•Male and female subjects between 18 and 55 years of age who have a diagnosis of multiple sclerosis (MS) as defined by McDonald et al., criteria #1-4 (McDonald et al., 2001, Section 22), and a baseline EDSS score between 0.0 and 5.5, inclusive.
•Randomized patients must have been treated with IFN beta-1a at either 22 or 44 mcg SC three times a week (TIW) for at least 9 months prior to randomization and must have experienced at least one medically documented clinical relapse on IFN beta-1a therapy within the 24 months prior to randomisation.
•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

•Primary progressive, secondary progressive, or progressive relapsing MS.
•MS relapse has occurred, in the opinion of the investigator, within 30 days prior to randomization AND/OR the subject has not stabilized from a previous relapse, in the opinion of the investigator, prior to randomization.
•A clinically significant infectious illness.
•History of malignancy.
•History of, or abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematological, hepatic, immunological, metabolic, agrological, pulmonary, gastrointestinal, dermatological, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent.
•History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
•Abnormal blood tests, performed at the screening visit.
•Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception (as defined by the investigator) during the study. The rhythm method is not to be used as the sole method of contraception.
•Nursing mothers, pregnant women, and women planning to become pregnant while on study.
•Previous participation in this study.
•Participation in any other investigational study within 6 months prior to randomization.

发起方

Biogen Idec GmbH