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

NCT ID: NCT03424733

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2020-05-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Current Plegridy Users

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.

Group Type: ACTIVE_COMPARATOR

Plegridy

Intervention Type: DRUG

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

Prednisone

Intervention Type: 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

Intervention Type: DRUG

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

New Plegridy Users

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.

Group Type: EXPERIMENTAL

Plegridy

Intervention Type: DRUG

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

Prednisone

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Plegridy

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

Intervention Type: 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.

Intervention Type: DRUG

Tylenol Pill

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

Intervention Type: DRUG

Other Intervention Names

Pegylated Interferon beta-1a; Acetaminophen

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Holy Name Medical Center, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Mary Ann Picone, MD

Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Holy Name Medical Center

Teaneck, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Ann Picone, MD

Role: CONTACT

m-picone@mail.holyname.org

201-837-0727

Facility Contacts

Mary Ann Picone, MD

Role: primary

M-picone@mail.holyname.org

201-837-0727

References

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.

Reference Type: RESULT

PMID: 9633761 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17588298 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15304586 (View on PubMed)

Other Identifiers

US-PEG-16-10990

Identifier Type: -

Identifier Source: org_study_id