Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects

Last updated: August 13, 2019
Sponsor: Holy Name Medical Center, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Neurologic Disorders

Memory Loss

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT03424733
US-PEG-16-10990
  • Ages > 18
  • All Genders

Study Summary

Some of the most common side effects of the multiple sclerosis drug Plegridy (pegylated interferon beta-1a) include flu-like symptoms and injection site reactions. Physicians often advise patients to take Tylenol or aspirin prior to injection, but in this study the investigators evaluated whether using a low dose of oral steroid in combination with Tylenol reduced flu-like symptoms and injection site reactions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosed any form of MS (relapsing remitting, primary progressive, secondaryprogressive), any EDSS (expanded stability status scale) score

Exclusion

Exclusion Criteria:

  • prior allergic reaction to interferon products, congestive heart failure, elevatedliver enzymes

Study Design

Total Participants: 50
Study Start date:
September 25, 2017
Estimated Completion Date:
May 31, 2020

Study Description

Multiple Sclerosis (MS) is a chronic neurological disease characterized by demyelination of the brain and spine. Currently, there are several treatments designed to decrease the frequency of attacks and delay disease progression. One of these treatments, interferon beta, has shown the potential to decrease relapse rates by approximately 30%, but because the body quickly clears these proteins, patients require more frequent dosing. Another interferon therapy called pegylated interferon beta-1a (Plegridy) was released and it was shown to last longer in the body than interferon beta-1a. This is why Plegridy can be take by an injection into tissue under the skin once every 14 days. However, some of the most common side effects of interferon beta therapy include flu-like symptoms and injection skin reactions, which can often cause patients to want to stop treatment. Clinical practitioners often advise patients to take acetaminophen (Tylenol) or aspirin before the injection in order to prevent the onset or decrease the severity of flu-like symptoms. A previous study with patients taking interferon beta-1a showed that taking a low dose oral steroid (prednisone) in addiction to a medication like Tylenol reduced flu-like symptoms compared to just taking Tylenol by itself. Because Plegridy lasts longer in the body and has more convenient dosing for patients, researchers in this study decided to investigate whether taking prednisone in addition to acetaminophen before the injection would help decrease or prevent the occurrence of flu-like symptoms and injection site reactions in patients taking the therapy.

Connect with a study center

  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

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