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

NCT03424733 — Phase 4, Unknown, 50 participants, Holy Name Medical Center, Inc.

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

Registry	NCT03424733
Status	Unknown
Phase	Phase 4
Study type	Interventional; non randomized, crossover, masking: none, prevention
Enrollment	50 (Estimated)
Sponsor	Holy Name Medical Center, Inc. (Other); collaborators: Biogen
Conditions	Multiple Sclerosis
Interventions	Plegridy, Prednisone, Tylenol Pill (Drug)
Dates	start 2017-09-25, primary completion 2020-05-01 (estimated), completion 2020-05-31 (estimated), first posted 2018-02-07, last updated 2019-08-15
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Current Plegridy Users	Active comparator	Drug: Plegridy; Drug: Prednisone; Drug: Tylenol Pill	Members in this group have been previously titrated and are currently taking the pegylated interferon beta-1 (Plegridy) injection once every two weeks. These patients will complete a total of six study injections of Plegridy (125 micrograms) totaling a 12 week study duration. Subjects must take two 325mg tablets of Tylenol 1 hour prior to each study injection, and one 20mg Prednisone tablet 4-5 hours prior to injections two through six only.
New Plegridy Users	Experimental	Drug: Plegridy; Drug: Prednisone; Drug: Tylenol Pill	Members in this group have never taken the pegylated interferon beta-1a (Plegridy) injection, and so they must first by titrated by injecting with a 63 and 94 microgram Plegridy dose. Titrations, along with full dose injections (125 micrograms) occur every two weeks. Patients must take two 325mg tablets of Tylenol prior to each titration injection. The third study dosage involves subjects taking the full 125 microgram Plegridy dosage with two 325mg Tylenol tablets prior to injection. The final five study injections (four through eight) require patients to take two 325mg Tylenol tablets 1 hour prior to injection, and one 20mg Prednisone tablet 4-5 hours prior to injection.

Plegridy (Drug), also known as Pegylated Interferon beta-1a: Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose
Prednisone (Drug): 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 (Drug), also known as Acetaminophen: Take two 325 milligram Tylenol tablets 1 hour prior to each Plegridy injection, irregardless of dosage.

+Outcome measures

Primary outcomes

Flu-like symptoms [12 to 16 weeks]: 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.

Secondary outcomes

Injection site reactions [12 to 16 weeks]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Holy Name Medical Center	Teaneck, New Jersey	United States	Recruiting

+Publications

Results publication: 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. PMID 9633761
Results publication: 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. PMID 17588298
Results publication: 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. PMID 15304586