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

NCT02234869 | Withdrawn Phase 4

• 1 other identifier: 105MS403
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Peginterferon Beta-1a; Relapsing Multiple Sclerosis; RMS; flu-like symptoms

Outcome Measures

Primary Outcomes (1)

• Combined Counts of adverse events (AEs) of flu-like symptoms, injection site reactions or injection site reaction pain

  Combined counts of AEs of flu-like symptoms (FLS) including chills, pyrexia, myalgia, and asthenia, injection site reactions (ISRs), and injection site reaction pain (ISR-P) over the first 6 months of treatment.

  6 Months

Secondary Outcomes (18)

• Change from Baseline in treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication-9 Items (TSQM-9)

  Baseline and Week 24

• Change from Baseline in adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) total score

  Baseline and Week 24

• Change from Baseline in the adapted MSTCQ Side Effects Score

  Baseline and Week 24

• Percentage of participants pain-free

  6 months

• Change from Baseline in mean change in VAS pain score from pre-injection to 30 minutes post-injection

  Baseline (pre-injection and 30-minutes after injection) and Week 24 (pre-injection and 30 minutes after injection)

Study Arms (2)

Peginterferon beta-1a

EXPERIMENTAL

Participants will receive peginterferon beta-1a, 125 µg subcutaneously once every 2 weeks during the 6-month comparator period of the study and during the 12-month extension period.

Drug: BIIB017 (Peginterferon beta-1a)

Interferon-β

ACTIVE COMPARATOR

Participants will continue to receive their standard-of-care interferon beta treatment for the first six months. During the 12-month extension period participants will switch to receive peginterferon beta-1a, 125 µg subcutaneously once every 2 weeks.

Drug: Interferon Beta; Drug: BIIB017 (Peginterferon beta-1a)

Interventions

Interferon Beta DRUG

Subcutaneous injection

Also known as: Rebif or Betaseron/Betaferon

Interferon-β

BIIB017 (Peginterferon beta-1a) DRUG

Single-use, disposable, prefilled pen for subcutaneous injection

Also known as: PEGylated interferon beta-1a (IFN β-1a)

Interferon-β; Peginterferon beta-1a

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a confirmed diagnosis of Relapsing Multiple Sclerosis (RMS), as defined by McDonald criteria.
• An Expanded Disability Status Scale (EDSS) score between 0 and 5.0.
• On continual treatment for ≥6 months with a single standard-of-care subcutaneous (SC) interferon beta (IFN-β) therapy, including IFN β-1b 0.25 mg SC every other day or IFN β-1a 44 μg SC 3 times weekly, and from a clinical perspective be able to continue this therapy (i.e., no significant untoward events attributed to IFN therapy that would preclude continuation of the existing IFN therapy).
• A candidate for change to BIIB017 therapy (candidacy for therapy change is determined by the treating physician; however, it is recommended to exclude patients with high disease activity and who are candidates for escalation therapy according to local guidelines).
• Patients who are randomized to their current standard-of-care IFN-β therapy for the first 6 months of the study must be willing to receive their treatment via the formulation provided in the study (i.e., Rebif 44 μg in a prefilled syringe or Betaferon/Betaseron 0.25 mg in single-use vials of lyophilized powder accompanied by a prefilled single-use diluent syringe).

You may not qualify if:

• Primary progressive, secondary progressive, or progressive relapsing MS.
• History of inadequate response to SC IFN therapy (as determined by the treating physician).
• History of severe allergic or anaphylactic reactions or known hypersensitivity to study drug or its excipients. - Known allergy to any component of the BIIB017 formulation.
• History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study.
• History of hypersensitivity or intolerance to acetaminophen, ibuprofen, naproxen, or aspirin that would preclude use of at least one of these during the study.
• An MS relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization.
• Any previous treatment with BIIB017.
• Treatment with other agents for MS.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Interventions

Interferon-beta; Interferon beta-1a; Interferon beta-1b; peginterferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 17, 2014

Record last verified: 2014-11