Recruiting

Prednisone with Pegylated Interferon Beta-1a

Sponsor:

Holy Name Medical Center, Inc.

Code:

NCT03424733

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Plegridy

Prednisone

Tylenol Pill

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT03424733

Start date

Sep 25, 2017

Status verified date

Aug, 2019

Completion date

May 31, 2020

Anticipated

Primary completion date

May 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Plegridy

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

Prednisone

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

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

Primary outcome measure

  • Flu-like symptoms [ Time Frame: 12 to 16 weeks ]

Central Contacts and Locations

Central contacts

Mary Ann Picone, MD

201-837-0727m-picone@mail.holyname.org

Locations

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Mary Ann Picone, MD

201-837-0727M-picone@mail.holyname.org

More Information

Sponsor

Holy Name Medical Center, Inc.

Last update posted

Aug 15, 2019

Last verified

Aug, 2019

Keywords

  • demyelination
  • relapse rate
  • Pegylated interferon beta-1a
  • side effects
  • flu-like symptoms
  • injection site reactions
  • prednisone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Holy Name Medical Center, Inc. on 2019-08-15.