Characterize Flu-like Symptoms in RRMS Patients Transitioning From IFN-B Therapies to Peginterferon Beta-1a (ALLOW)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01939002
First received: August 23, 2013
Last updated: July 16, 2015
Last verified: July 2015
  Purpose

The primary objective of this study is to determine the proportion of relapsing multiple sclerosis (RMS) participants who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated interferon beta (IFN-β) therapies to peginterferon beta-1a (BIIB017).

Secondary objectives are: To determine the severity and frequency (measured by flu-like symptom score [FLS-S]) of FLS in these participants; To determine the duration (measured in number of hours) of FLS in these participants; To determine the effectiveness and participants' satisfaction with FLS management as measured by an FLS visual analog scale (FLS-VAS); To determine the effect of peginterferon beta-1a on other participant reported outcomes (PROs) including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the Patient Determined Disease Steps [PDDS]) over a 56-week period; To determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); To assess the use of additional medications (in addition to current medications used to treat FLS) to relieve peginterferon beta-1a -related FLS; to determine the incidence of adverse events (AEs) throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β (interferon beta) therapy to peginterferon beta-1a.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: peginterferon beta-1a
Drug: naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open- Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Proportion of Participants Experiencing New or Increased FLS as Measured by the Total FLS-S [ Time Frame: Day 1 up to 48 weeks ] [ Designated as safety issue: Yes ]
    Increased FLS is defined as an increase >=2.0 points in the total FLS-S, which has a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS on all four symptom scores.


Secondary Outcome Measures:
  • Frequency and severity of FLS measured by FLS-S [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: No ]
  • Duration of FLS [ Time Frame: Day 1 up to 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants who experience FLS during the first 8 weeks [ Time Frame: Day 1 up to 48 weeks ] [ Designated as safety issue: No ]
  • Severity and frequency of FLS as measured by FLS-S during the first 8 weeks [ Time Frame: Day 1 up to 8 Weeks ] [ Designated as safety issue: No ]
  • Duration of each FLS during the first 8 weeks [ Time Frame: Day 1 up to 8 Weeks ] [ Designated as safety issue: No ]
  • Percentage of participants who need additional FLS management regimen to relieve peginterferon beta-1a- related FLS [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: No ]
  • Change from Screening Visit (Week -4) to Week 48 in Patient-Reported treatment satisfaction as measured with the TSQM [ Time Frame: Week -4 (screening), Week 48 or end of study ] [ Designated as safety issue: No ]
    TSQM is a 14-item, validated questionnaire that will assess participants' satisfaction with treatment and will capture information on treatment side effects, effectiveness, and convenience. In addition, a fourth component captures the global satisfaction with the treatment.

  • Change from Screening Visit (Week -4) to Week 48 in Participant-Reported Absenteeism resulting from FLS [ Time Frame: Week -4 (screening), Week 48 or end of study ] [ Designated as safety issue: No ]
  • Change from Baseline Visit (Day 1) to Week 48 in Participant Disability Status as Measured by PDDS [ Time Frame: Day 1 (baseline, pre-dose), Week 48 or end of study ] [ Designated as safety issue: No ]
    PDDS is a self-report questionnaire that contains a single item for measuring self-reported disability using an 8-level ordinal scale.

  • The number of Participants that experience AEs and Serious Adverse Events (SAEs) [ Time Frame: Up to week 52 ] [ Designated as safety issue: Yes ]
  • The number of Participants that discontinue study treatment due to an AE [ Time Frame: Up to week 52 ] [ Designated as safety issue: Yes ]
  • Change from Screening (Weeks -4 to -1) to the last four weeks of study (Weeks 45-48) in Duration of FLS [ Time Frame: Weeks -4 to -1 (screening), Weeks 45-48 (last four weeks of study) ] [ Designated as safety issue: No ]
  • The number of participants who test positive for Interferon-beta 1a binding antibodies (IFN β-1a BAbs) [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: No ]
  • The number of participants who test positive for IFN β-1a Nabs [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: No ]
  • The number of participants who test positive for Interferon-beta 1a anti-PEG antibodies [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: No ]
  • Effectiveness and participants' satisfaction with FLS management as measured by FLS-VAS [ Time Frame: Day 1 up to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peginterferon beta-1a plus current FLS therapy
peginterferon beta-1a initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
Drug: peginterferon beta-1a
Administered as specified in the treatment arm
Other Names:
  • Plegridy
  • BIIB017
  • PEGylated Interferon Beta-1a
  • PEG IFN β-1a
Experimental: peginterferon beta-1a plus naproxen
peginterferon beta-1a initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to peginterferon beta-1a treatment and continuing for 48 hours following the peginterferon beta-1a injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
Drug: peginterferon beta-1a
Administered as specified in the treatment arm
Other Names:
  • Plegridy
  • BIIB017
  • PEGylated Interferon Beta-1a
  • PEG IFN β-1a
Drug: naproxen
Administered as specified in the treatment arm
Other Names:
  • Naproxen Sodium
  • Aleve
  • NSAID
  • long-acting nonsteroidal anti-inflammatory drug

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have a confirmed diagnosis of relapsing forms of MS, as defined by McDonald criteria #1-4 [Polman 2005].
  • Must have neurological findings consistent with an EDSS score of 0.0 - 5.0
  • Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening.
  • All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.

Key Exclusion Criteria:

  • Primary progressive, secondary progressive, or progressive relapsing MS [Lublin and Reingold 1996]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement.
  • History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to interferon beta-1a or polyethylene glycol..
  • History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
  • History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline.
  • Known allergy to any component of the peginterferon beta-1a formulation.
  • An MS relapse that has occurred within the 50 days prior to baseline (Day 1) and/or lack of stabilization from a previous relapse prior to baseline.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939002

  Show 37 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01939002     History of Changes
Other Study ID Numbers: 105MS303
Study First Received: August 23, 2013
Last Updated: July 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen:
flu-like symptoms

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Interferon beta 1a
Interferon-beta
Naproxen
Adjuvants, Immunologic
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2015