Last updated on July 2019

OBS14379-A prospective observational cohort study in adult patients with relapsing multiple sclerosis to assess patient safety during and after LEMTRADA® (alemtuzumab) infusions of the first treatment course


Brief description of study

OBS14379-A prospective observational cohort study in adult patients with relapsing multiple sclerosis to assess patient safety during and after LEMTRADA® (alemtuzumab) infusions of the first treatment course

Detailed Study Description

Multiple sclerosis (MS) is a chronic and often disabling disorder of the central nervous system involving damage to the brain, optic nerves and spinal cord. Most patients initially present with relapsing remitting MS, experiencing unpredictable episodes of transient neurological deterioration (relapse) followed by a variable period of recovery (remission) during which they may or may not fully recover.

LEMTRADA™ (Alemtuzumab) Alemtuzumab is approved in >40 countries for the treatment of patients with Relapsing forms of Multiple Sclerosis (RMS ), with the trade name LEMTRADA™. The approved LEMTRADA regimen is 12 mg/day administered by intravenous infusion for 2 treatment courses. • Initial treatment course: 12 mg/day for 5 consecutive days (60 mg total dose). • Second treatment course: 12 mg/day for 3 consecutive days (36 mg total dose) administered 12 months after the initial treatment course.

The active ingredient in LEMTRADA has also been used in treatment of disorders other than MS.

Alemtuzumab was approved in 2001 as treatment for chronic B-cell lymphocytic leukemia under the trade names Campath® and MabCampath®. Refer to approved national label (eg, US Prescriber Information, US PI) of LEMTRADA for additional information.

RATIONALE

Administration of LEMTRADA commonly elicits infusion reactions. In clinical studies, infusion associated reactions (IARs), defined as any adverse event (AE) occurring during or within 24 hours of LEMTRADA infusion, occurred in 92% of LEMTRADA-treated patients. In some patients, infusion reactions were reported more than 24 hours after LEMTRADA infusion. Most IARs were of mild to moderate intensity. The most common were headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnoea, dysgeusia, chest discomfort, generalized rash, tachycardia, dyspepsia, dizziness, and pain. Serious reactions occurred in 3% of patients and included anaphylaxis (including anaphylactic shock), angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia (including atrial fibrillation), transient neurologic symptoms, hypertension, headache, pyrexia, and rash. During post-marketing use in patients with disorders other than MS, Campath or MabCampath administration, generally at higher and more frequent doses than recommended in MS, has been associated with serious, including fatal, infusion reactions.

The safety profile of LEMTRADA during clinical development program was documented mostly by adverse event collection and analysis. Vital signs during LEMTRADA infusions and post infusion were not systematically recorded during most of the clinical development program.

This study is designed to further characterize the safety profile of LEMTRADA by systematic vital sign observation during and shortly after LEMTRADA infusions of the first treatment course. Since the incidence of adverse reactions in LEMTRADA clinical trials was highest in the first treatment course, vital sign observations during this course will add meaningful characterization of the safety profile of the drug.

Clinical Study Identifier: TX143844

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