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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03424733
• Date of registration: 31/01/2018
• Prospective Registration: No
• Primary sponsor: Holy Name Medical Center, Inc.
• Public title: Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects
• Scientific title: A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a
• Date of first enrolment: September 25, 2017
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03424733
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Mary Ann Picone, MD

• Name: Mary Ann Picone, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Prednisone

Drug: Tylenol Pill

Drug: Plegridy

Primary Outcome(s)

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

Secondary Outcome(s)

Injection site reactions [Time Frame: 12 to 16 weeks]

Secondary ID(s)

US-PEG-16-10990

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen