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

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ClinicalTrials.gov Identifier: NCT03424733
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Mary Ann Picone, MD, Holy Name Medical Center, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Plegridy Drug: Prednisone Drug: Tylenol Pill Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients in both arms first take Tylenol and then take Tylenol in combination with Prednisone.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018


Arm Intervention/treatment
Active Comparator: 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.
Drug: Plegridy
Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose
Other Name: Pegylated Interferon beta-1a

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.
Other Name: Acetaminophen

Experimental: 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.
Drug: Plegridy
Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose
Other Name: Pegylated Interferon beta-1a

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.
Other Name: Acetaminophen




Primary Outcome Measures :
  1. Flu-like symptoms [ Time Frame: 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 Outcome Measures :
  1. Injection site reactions [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424733


Locations
United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Mary Ann Picone, MD    551-208-3003    M-picone@mail.holyname.org   
Contact: Karen Blitz, DO    516-316-0719    K-blitz@holyname.org   
Sponsors and Collaborators
Holy Name Medical Center, Inc.
Biogen

Publications of Results:
Responsible Party: Mary Ann Picone, MD, Neurologist, Holy Name Medical Center, Inc.
ClinicalTrials.gov Identifier: NCT03424733     History of Changes
Other Study ID Numbers: US-PEG-16-10990
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mary Ann Picone, MD, Holy Name Medical Center, Inc.:
demyelination
relapse rate
Pegylated interferon beta-1a
side effects
flu-like symptoms
injection site reactions
prednisone

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Prednisone
Interferon-beta
Interferon beta-1a
Acetaminophen
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Immunologic Factors
Adjuvants, Immunologic