NCT02234869

Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy

Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate, in participants with RMS, safety and tolerability (as defined by the frequency of adverse events \[AEs\] of flu-like symptoms \[FLS; chills, pyrexia, myalgia, and asthenia\], injection site reactions \[ISRs\], and injection site reaction pain \[ISR-P\]) over 6 months of treatment (the active comparator period) with BIIB017 125 μg subcutaneously (SC) every 2 weeks versus standard-of-care SC interferon-beta (IFN-β) therapy. Secondary objectives of this study are to assess the following measures during the first (6-month) period of the study in participants treated with BIIB017 versus standard-of-care SC IFN-β therapy: patient-reported treatment satisfaction using the following patient-reported outcome measures (PROMs): Treatment Satisfaction Questionnaire for Medication (TSQM-9), Adapted MS Treatment Concerns Questionnaire (MSTCQ), Adapted MSTCQ Side Effects Score, Pain using a visual analog scale (VAS) diary and the McGill Pain Questionnaire Short Form (SF-MPQ), the treatments' impact on RMS using the following PROMs: Multiple Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale-5 Item (MFIS-5), EuroQol Group 5-Dimension 3-Level Version (EQ-5D-3L), Health-Related Productivity Questionnaire (HRPQ), Beck Depression Inventory, second edition (BDI-II), participant adherence to study treatment, clinical status as measured by the Expanded Disability Status Scale (EDSS) and relapse activity, safety and tolerability of study treatment after a change in standard-of-care SC IFN-β therapy and the immunogenicity profiles of participants changing from standard-of-care SC IFN-β to BIIB017.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon Beta	Subcutaneous injection
DRUG	BIIB017 (Peginterferon beta-1a)	Single-use, disposable, prefilled pen for subcutaneous injection

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-02-01
• Completion: 2018-03-01
• First posted: 2014-09-09
• Last updated: 2014-11-17