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

Multiple Sclerosis Clinical Trial

Official title:

A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424733
• Other study ID #: US-PEG-16-10990
• Status: Recruiting
• Phase: Phase 4
• Start date: September 25, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2019
• Source: Holy Name Medical Center, Inc.
• Contact: Mary Ann Picone, MD
• Phone: 201-837-0727
• Email: m-picone[@]mail.holyname.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Plegridy
Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose
• Prednisone
Take one 20 milligram prednisone tablet four to five hours prior to injections two through six of the full 125 microgram Plegridy dose.
• Tylenol Pill
Take two 325 milligram Tylenol tablets 1 hour prior to each Plegridy injection, irregardless of dosage.

Locations

Country	Name	City	State
United States	Holy Name Medical Center	Teaneck	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Holy Name Medical Center, Inc.	Biogen

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brandes DW, Bigley K, Hornstein W, Cohen H, Au W, Shubin R. Alleviating flu-like symptoms with dose titration and analgesics in MS patients on intramuscular interferon beta-1a therapy: a pilot study. Curr Med Res Opin. 2007 Jul;23(7):1667-72. — View Citation

Río J, Nos C, Bonaventura I, Arroyo R, Genis D, Sureda B, Ara JR, Brieva L, Martín J, Saiz A, Sánchez López F, Prieto JM, Roquer J, Dorado JF, Montalban X. Corticosteroids, ibuprofen, and acetaminophen for IFNbeta-1a flu symptoms in MS: a randomized trial — View Citation

Río J, Nos C, Marzo ME, Tintoré M, Montalban X. Low-dose steroids reduce flu-like symptoms at the initiation of IFNbeta-1b in relapsing-remitting MS. Neurology. 1998 Jun;50(6):1910-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flu-like symptoms	Reduced flu-like symptoms from Plegridy injections due to taking both Tylenol and Prednisone prior to treatment. Flu-like symptoms are measured every 6 hours for 48 hours after injection by patients self reporting their muscle aches, temperature, chills, and fatigue on a Holy Name administered Flu-like symptom questionnaire.	12 to 16 weeks
Secondary	Injection site reactions	Reduced injection site reactions from Plegridy injections due to taking both Tylenol and Prednisone prior to injection. Injection site reactions are reported to a clinical research assistant approximately one week after injection. If present, patients must record their injection site reactions using a Holy Name administered tape measurer in centimeters, as well as descriptive characteristics of the injection (location on body, swelling, redness, itching, and pain). The clinical research assistant records all of the data on an injection site reaction form.	12 to 16 weeks