- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02234869
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
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- 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
Ages Eligible for Study
16 years to 63 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 |
Intervention / Treatment |
---|---|
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.
|
Single-use, disposable, prefilled pen for subcutaneous injection
Other Names:
|
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.
|
Single-use, disposable, prefilled pen for subcutaneous injection
Other Names:
Subcutaneous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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
October 1, 2014
Primary Completion (Anticipated)
February 1, 2017
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
September 5, 2014
First Submitted That Met QC Criteria
September 5, 2014
First Posted (Estimate)
September 9, 2014
Study Record Updates
Last Update Posted (Estimate)
November 17, 2014
Last Update Submitted That Met QC Criteria
November 14, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon beta-1a
- Interferon-beta
- Interferon beta-1b
Other Study ID Numbers
- 105MS403
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsing Multiple Sclerosis
-
BiogenWithdrawnRelapsing-Remitting Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenAbbVieTerminatedMultiple Sclerosis | Relapsing-Remitting Multiple SclerosisUnited States, Denmark, Italy, United Kingdom, Czechia, Canada, Hungary, Spain, Australia, Israel, Georgia, Serbia, Russian Federation, Ukraine, India, Poland, Brazil, France, Argentina, Germany, Greece, Ireland, Mexico, Moldova, Republic... and more
-
EMD SeronoPfizerCompletedRelapsing-remitting Multiple SclerosisUnited States, United Kingdom, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russian Federation, Spain, Switzerland
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)CompletedRelapsing-Remitting Multiple SclerosisUnited States
-
BiogenTerminatedRelapsing-Remitting Multiple SclerosisUnited States, Spain, Germany, Australia, Sweden, Czechia, France, Italy, United Kingdom
-
Novartis PharmaceuticalsWithdrawnMultiple Sclerosis (Relapsing Remitting)
-
Genzyme, a Sanofi CompanyTerminatedRelapsing-remitting Multiple SclerosisSweden, Poland, Russian Federation, United States, Canada
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple SclerosisGermany
Clinical Trials on BIIB017 (Peginterferon beta-1a)
-
BiogenCompleted
-
BiogenCompletedMultiple Sclerosis | HealthyUnited States
-
BiogenCompleted
-
BiogenCompleted
-
BiogenCompletedRelapsing-Remitting Multiple Sclerosis (RRMS)Italy
-
BiogenRecruitingMultiple Sclerosis, Relapsing-RemittingSpain, Germany, Croatia, Turkey, Saudi Arabia, Hungary, Belgium, Australia, France, Portugal, Slovakia, United States, Bulgaria, Greece, Kuwait, Russian Federation, Tunisia, Italy, Argentina, Czechia, Israel, Serbia
-
BiogenCompletedRelapsing Forms of Multiple SclerosisUnited States, Italy, Switzerland, Canada, Australia, Germany, Spain, France, Portugal, Netherlands, United Kingdom, Denmark, Austria, Ireland
-
BiogenCompletedRelapsing Multiple SclerosisUnited States, Croatia, Russian Federation, India, Spain, New Zealand, Canada, Belgium, Netherlands, Bulgaria, Serbia, Greece, Ukraine, Mexico, Georgia, Colombia, Germany, Poland, United Kingdom, Czech Republic, France, Chile, Romania, Eston... and more
-
BiogenCompletedRelapsing Remitting Multiple SclerosisPortugal
-
BiogenCompletedRelapsing Multiple SclerosisUnited States, Germany, Russian Federation, India, New Zealand, Spain, Belgium, Colombia, Canada, Bulgaria, Serbia, Greece, Peru, Ukraine, Poland, United Kingdom, Croatia, France, Romania, Chile, Czech Republic, Mexico, Estonia, Georgia, Latv... and more