Clinical trial NCT03424733: Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects
Official title: A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: demyelination
relapse rate
Pegylated interferon beta-1a
side effects
flu-like symptoms
injection site reactions
prednisone
Lead sponsor: Holy Name Medical Center, Inc.
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2018-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients in both arms first take Tylenol and then take Tylenol in combination with Prednisone.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Flu-like symptoms
timeFrame: 12 to 16 weeks
Secondary outcomes:
measure: Injection site reactions
timeFrame: 12 to 16 weeks
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
Study officials:
References:
citation: Rio J, Nos C, Marzo ME, Tintore 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. doi: 10.1212/wnl.50.6.1910.
citation: 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. doi: 10.1185/030079907x210741.
citation: Rio J, Nos C, Bonaventura I, Arroyo R, Genis D, Sureda B, Ara JR, Brieva L, Martin J, Saiz A, Sanchez Lopez F, Prieto JM, Roquer J, Dorado JF, Montalban X. Corticosteroids, ibuprofen, and acetaminophen for IFNbeta-1a flu symptoms in MS: a randomized trial. Neurology. 2004 Aug 10;63(3):525-8. doi: 10.1212/01.wnl.0000133206.44931.25.