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

November 14, 2014 updated by: Biogen

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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).

Key Exclusion Criteria:

  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peginterferon beta-1a
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)
Single-use, disposable, prefilled pen for subcutaneous injection
Other Names:
  • PEGylated interferon beta-1a (IFN β-1a)
Active Comparator: Interferon-β
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: BIIB017 (Peginterferon beta-1a)
Single-use, disposable, prefilled pen for subcutaneous injection
Other Names:
  • PEGylated interferon beta-1a (IFN β-1a)
Drug: Interferon Beta
Subcutaneous injection
Other Names:
  • Rebif or Betaseron/Betaferon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Combined Counts of adverse events (AEs) of flu-like symptoms, injection site reactions or injection site reaction pain
Time Frame: 6 Months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication-9 Items (TSQM-9)
Time Frame: Baseline and Week 24
The TSQM-9 is a 9-item, validated questionnaire that assesses participants' satisfaction with treatment and captures information on treatment effectiveness, convenience, and overall satisfaction.
Baseline and Week 24
Change from Baseline in adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) total score
Time Frame: Baseline and Week 24
The adapted MSTCQ self-administered questionnaire includes evaluation of the injection process, treatment differences, overall injection issues, FLS, and ISRs.
Baseline and Week 24
Change from Baseline in the adapted MSTCQ Side Effects Score
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of participants pain-free
Time Frame: 6 months
Pain free is defined as a score of 0 for all full-dose injections measured on a visual analog scale (VAS) diary of patient-reported pain. The scale ranges from 0 (no pain) to 10 (worse possible pain).
6 months
Change from Baseline in mean change in VAS pain score from pre-injection to 30 minutes post-injection
Time Frame: Baseline (pre-injection and 30-minutes after injection) and Week 24 (pre-injection and 30 minutes after injection)
Pain was measured on a visual analog scale (VAS) prior to injection and 30 minutes after injection. The VAS scale ranges from 0 (no pain) to 10 (worse possible pain).
Baseline (pre-injection and 30-minutes after injection) and Week 24 (pre-injection and 30 minutes after injection)
Change from Baseline in mean McGill Pain Questionnaire Short Form (SF-MPQ) VAS pain score
Time Frame: Baseline and Week 24
This self-administered questionnaire provides qualitative measures of clinical pain that captures its sensory, affective, and other qualitative components.
Baseline and Week 24
Change from Baseline in the Multiple Sclerosis Impact Scale-29 items (MSIS-29) score
Time Frame: Baseline and Week 24
The MSIS-29 is a self-report questionnaire measuring the physical (20 items) and psychological (9 items) impact of MS from the patient's perspective. Each of the 29 questions can take 1 of 5 responses, ranging from 1 (not at all) to 5 (extremely). Combined scores for MSIS-29 scales are generated by summing items, with a total score ranging from 29 to 145.
Baseline and Week 24
Change from Baseline in the Modified Fatigue Impact Scale-5 Item (MFIS-5) score
Time Frame: Baseline and Week 24
The MFIS-5 is a structured, self-report questionnaire, modified from the Fatigue Impact Scale. The abbreviated version (MFIS-5) has 5 items taken from the physical (2 items), cognitive (2 items), and psychological (1 item) subscales of the standard 21-item MFIS. The participant is asked to score each item from 0 to 4. All items are scaled so that higher scores indicate a greater impact of fatigue on a participant's activities. The MFIS-5 total score consists of the sum of the raw scores on the 5 items, and thus can range from 0 to 20.
Baseline and Week 24
Change from Baseline in the EuroQol-5-dimension 3-level version (EQ-5D-3L) index
Time Frame: Baseline and Week 24
The EQ-5D-3L is a descriptive system of health-related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension.
Baseline and Week 24
Change from Baseline in the Health-Related Productivity Questionnaire (HRPQ) score
Time Frame: Baseline and Week 24
This self-administered questionnaire provides information about absenteeism and presenteeism over the previous week and includes an estimate of unproductive work time.
Baseline and Week 24
Change from Baseline in the Beck Depression Inventory, second edition (BDI-II) score
Time Frame: Baseline and Week 24
BDI-II is a 21-item self-administered questionnaire to assess the intensity of depression.
Baseline and Week 24
Percentage of participants with changes in Clinical Status assessed using the Expanded Disability Status Scale (EDSS)
Time Frame: Up to 6 months
The EDSS is a method of quantifying disability in MS. The EDSS is an ordinal clinical rating scale based on a standard neurological exam, with scores ranging from 0 (normal neurological exam) to 10 (death due to MS) in half-point increments.
Up to 6 months
Annualized relapse rate (ARR)
Time Frame: 6 months
The ARR is calculated by dividing the number of relapses the participants experience during a 1-year period by the number of participants.
6 months
Percentage of participants with relapse
Time Frame: 6 months
A clinical relapse is defined as new or recurrent neurological symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings on examination by a neurologist.
6 months
Adherence to study treatment measured by returned autoinjectors/syringes
Time Frame: 6 months
6 months
Adherence to study treatment measured by the treatment adherence questionnaire
Time Frame: 6 months
6 months
Number of participants with adverse events (AEs), serious adverse events (SAEs), and discontinuations of study treatment due to an AE
Time Frame: 6 months
6 months
Number of participants with IFN β-1a and IFN β-1b binding and neutralizing antibodies, and poly(ethylene glycol) (PEG)-binding antibodies
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 105MS403

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