Clareo Health | A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of RRMS according to the McDonald criteria
Treatment-naïve in respect to natalizumab as disease modifying monotherapy for RRMS
No or not more than one prior MS disease-modifying therapy
Highly active RRMS, as defined by at least one relapse in the previous year and at least one T1 gadolinium-enhancing lesion or ≥3 new or enlarging T2 lesions
EDSS score ≤ 5.5 at Screening
Estimated glomerular filtration rate (eGFR) \>30 millilitre per min (mL/min), as estimated using the Cockcroft-Gault formula.
You may not be if
Primary- and secondary-progressive MS
Participants for whom MRI is contraindicated
History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study
History of severe allergic or anaphylactic reactions or known hypersensitivity to any antibody drug therapy.
