Relapsing Multiple SclerosisPhase 4FrequencyNCT02234869
Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy
A Phase 4 study testing Interferon Beta and BIIB017 (Peginterferon beta-1a) in people with Relapsing Multiple Sclerosis, run by Biogen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Interferon Beta and BIIB017 (Peginterferon beta-1a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Any previous treatment with BIIB017.
- Treatment with other agents for MS.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
About this study
Official title: 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.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Interferon Beta, BIIB017 (Peginterferon beta-1a)
- Keywords
- Peginterferon Beta-1a, Relapsing Multiple Sclerosis, RMS, flu-like symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon BetaDrug
Also called Rebif or Betaseron/Betaferon
Subcutaneous injection
BIIB017 (Peginterferon beta-1a)Drug
Also called PEGylated interferon beta-1a (IFN β-1a)
Single-use, disposable, prefilled pen for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Interferon Beta; Drug: BIIB017 (Peginterferon beta-1a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (18)
Change from Baseline in treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication-9 Items (TSQM-9)
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.
Measured: Baseline and Week 24
Change from Baseline in adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) total score
The adapted MSTCQ self-administered questionnaire includes evaluation of the injection process, treatment differences, overall injection issues, FLS, and ISRs.
Measured: Baseline and Week 24
Change from Baseline in the adapted MSTCQ Side Effects Score
Measured: Baseline and Week 24
Percentage of participants pain-free
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).
Measured: 6 months
Change from Baseline in mean change in VAS pain score from pre-injection to 30 minutes post-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).
Measured: 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
This self-administered questionnaire provides qualitative measures of clinical pain that captures its sensory, affective, and other qualitative components.
Measured: Baseline and Week 24
Change from Baseline in the Multiple Sclerosis Impact Scale-29 items (MSIS-29) score
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.
Measured: Baseline and Week 24
Change from Baseline in the Modified Fatigue Impact Scale-5 Item (MFIS-5) score
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.
Measured: Baseline and Week 24
Change from Baseline in the EuroQol-5-dimension 3-level version (EQ-5D-3L) index
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.
Measured: Baseline and Week 24
Change from Baseline in the Health-Related Productivity Questionnaire (HRPQ) score
This self-administered questionnaire provides information about absenteeism and presenteeism over the previous week and includes an estimate of unproductive work time.
Measured: Baseline and Week 24
Change from Baseline in the Beck Depression Inventory, second edition (BDI-II) score
BDI-II is a 21-item self-administered questionnaire to assess the intensity of depression.
Measured: Baseline and Week 24
Percentage of participants with changes in Clinical Status assessed using the Expanded Disability Status Scale (EDSS)
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.
Measured: Up to 6 months
Annualized relapse rate (ARR)
The ARR is calculated by dividing the number of relapses the participants experience during a 1-year period by the number of participants.
Measured: 6 months
Percentage of participants with relapse
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.
Measured: 6 months
Adherence to study treatment measured by returned autoinjectors/syringes
Measured: 6 months
Adherence to study treatment measured by the treatment adherence questionnaire
Measured: 6 months
Number of participants with adverse events (AEs), serious adverse events (SAEs), and discontinuations of study treatment due to an AE
Measured: 6 months
Number of participants with IFN β-1a and IFN β-1b binding and neutralizing antibodies, and poly(ethylene glycol) (PEG)-binding antibodies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2017 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Due to a change in Biogen Idec's medical research plans.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234869
- Sponsor's protocol ID
- 105MS403
- Acronym
- Frequency
- Status last verified
- Nov 2014
- First submitted
- 5 Sep 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02234869
- Acronym / sponsor ID
- Frequency / 105MS403
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Peginterferon Beta-1a, Relapsing Multiple Sclerosis, RMS, flu-like symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a change in Biogen Idec's medical research plans.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon beta-1a | Experimental | Drug: BIIB017 (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. |
| Interferon-β | Active comparator | Drug: Interferon Beta, Drug: BIIB017 (Peginterferon beta-1a)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon BetaAlso: Rebif or Betaseron/BetaferonSubcutaneous injection | Drug | Interferon-β |
| BIIB017 (Peginterferon beta-1a)Also: PEGylated interferon beta-1a (IFN β-1a)Single-use, disposable, prefilled pen for subcutaneous injection | Drug | Interferon-β, Peginterferon beta-1a |
Primary outcome
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.
18 secondary outcomes
Change from Baseline in treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication-9 Items (TSQM-9)
Time frame: Baseline and Week 24
Change from Baseline in adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) total score
Time frame: Baseline and Week 24
Change from Baseline in the adapted MSTCQ Side Effects Score
Time frame: Baseline and Week 24
Percentage of participants pain-free
Time frame: 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)
Change from Baseline in mean McGill Pain Questionnaire Short Form (SF-MPQ) VAS pain score
Time frame: Baseline and Week 24
Change from Baseline in the Multiple Sclerosis Impact Scale-29 items (MSIS-29) score
Time frame: Baseline and Week 24
Change from Baseline in the Modified Fatigue Impact Scale-5 Item (MFIS-5) score
Time frame: 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
Change from Baseline in the Health-Related Productivity Questionnaire (HRPQ) score
Time frame: Baseline and Week 24
Change from Baseline in the Beck Depression Inventory, second edition (BDI-II) score
Time frame: 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
Annualized relapse rate (ARR)
Time frame: 6 months
Percentage of participants with relapse
Time frame: 6 months
Adherence to study treatment measured by returned autoinjectors/syringes
Time frame: 6 months
Adherence to study treatment measured by the treatment adherence questionnaire
Time frame: 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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interferon Beta and BIIB017 (Peginterferon beta-1a) in people with Relapsing Multiple Sclerosis, run by Biogen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Counts of adverse events (AEs) of flu-like symptoms, injection site reactions or injection site reaction pain (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.