A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study

CL Biomedicine R&D Unit0 个研究点目标入组 100 人开始时间: 2006年2月17日最近更新: 2012年4月3日

研究概览

暂无简介。

•Confirmed diagnosis of MS according to the McDonald criteria (Appendix 1).
•Current treatment with Rebif® (22 or 44) s.c. TIW for at least 6 months or more
•Two consecutive positive NAb titres of ?20NU at least 4 weeks apart.
•Age over 18 years and less than 65 years.
•Expanded Disability Status Scale (EDSS) score not to exceed 6.5.
•Women of childbearing potential must agree to practice adequate contraception methods, defined as barrier methods with spermicide, surgical sterilisation of self or male partner, combined oral contraceptives or intrauterine device/system. All female subjects who are not post-menopausal or surgically sterile must have a negative blood pregnancy test at screening.
•Must give written informed consent and authorise the release and use of protected health information, as required by local law.
•Able and willing to undergo blood sampling at regular intervals as defined by the protocol.
•Able to comply with study requirements.
•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

•Treatment with other immunosuppressive, immunomodulatory, or experimental treatments within the last 6 months of enrollment in the study, but excluding pulsed intravenous or oral steroids for treatment of MS relapse.
•Patients presenting a severe or unstable disorder: poorly controlled diabetes, arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, clinically significant laboratory abnormality, or any medical condition which, in the opinion of the chief investigator, would pose additional risk in administering IFNß-1b to the patient.
•Presence of chronic or recurrent infection.
•Exposure to any other investigational drug within 30 days of enrollment in the study.
•History of malignancy unless an exception is granted by the Chief Investigator.
•History of human immunodeficiency virus (HIV).
•History of drug or alcohol abuse within 6 months prior to enrollment into the study.

发起方

CL Biomedicine R&D Unit