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

NCT03424733 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-08-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

Plegridy

Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose

DRUG

Prednisone

Take one 20 milligram prednisone tablet four to five hours prior to injections two through six of the full 125 microgram Plegridy dose.

DRUG

Tylenol Pill

Take two 325 milligram Tylenol tablets 1 hour prior to each Plegridy injection, irregardless of dosage.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Holy Name Medical Center, Inc.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2020-05-01
Completion
2020-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03424733 on ClinicalTrials.gov