Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
With
AbbVie
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:
* Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
* Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
You may not be if
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of malignancy
History of severe allergic or anaphylactic reactions or known drug hypersensitivity
History of abnormal laboratory results based on investigator judgment
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
History of drug or alcohol abuse within the 2 years prior to randomization
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
Exposure to varicella zoster virus within 21 days before Screening.
Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase \>2 times the upper limit of normal (ULN) and serum creatinine \>ULN.
Clareo Health | Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
