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 : August 15, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Plegridy Drug: Prednisone Drug: Tylenol Pill | Phase 4 |
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 : | May 1, 2020 |
Estimated Study Completion Date : | May 31, 2020 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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.
- 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 |
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

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
Contact: Mary Ann Picone, MD | 201-837-0727 | m-picone@mail.holyname.org |
United States, New Jersey | |
Holy Name Medical Center | Recruiting |
Teaneck, New Jersey, United States, 07666 | |
Contact: Mary Ann Picone, MD 201-837-0727 M-picone@mail.holyname.org |
Responsible Party: | Mary Ann Picone, MD, Neurologist, Holy Name Medical Center, Inc. |
ClinicalTrials.gov Identifier: | NCT03424733 |
Other Study ID Numbers: |
US-PEG-16-10990 |
First Posted: | February 7, 2018 Key Record Dates |
Last Update Posted: | August 15, 2019 |
Last Verified: | August 2019 |
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 |
demyelination relapse rate Pegylated interferon beta-1a side effects |
flu-like symptoms injection site reactions prednisone |
Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Acetaminophen Interferons Interferon-beta Interferon beta-1a Prednisone Anti-Inflammatory Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiviral Agents Anti-Infective Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antipyretics Immunologic Factors Adjuvants, Immunologic |