BIIB017 (PEGylated Interferon Beta-1a) Related Flu-Like Symptoms in Relapsing Multiple Sclerosis Participants (ALLOW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01939002
First received: August 23, 2013
Last updated: August 29, 2014
Last verified: August 2014
  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 BIIB017 (PEGylated Interferon Beta-1a). 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 effect of BIIB017 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 BIIB017-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 therapy to BIIB017.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: BIIB017 (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 Idec:

Primary Outcome Measures:
  • Proportion of Participants Experiencing New or Increased Flu-like Symptoms (FLS)as Measured by the Total Flu-like Symptom Score (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 flu-like symptoms (FLS) (measured by flu-like symptom score [FLS-S]). [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: Yes ]
  • Duration of flu-like symptoms (FLS). [ Time Frame: Day 1 up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of participants who experience flu-like symptoms (FLS) during the first 8 weeks [ Time Frame: Day 1 up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Severity and frequency of flu-like symptoms (FLS) as measured by flu-like symptom score (FLS-S) during the first 8 weeks [ Time Frame: Day 1 up to 8 Weeks ] [ Designated as safety issue: Yes ]
  • Duration of each flu-like symptom (FLS) during the first 8 weeks [ Time Frame: Day 1 up to 8 Weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who need additional flu-like symptoms (FLS) management regimen to relieve BIIB017-related FLS [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Screening Visit (Week -4) to Week 48 in Patient-Reported treatment satisfaction as measured with the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Week -4 (screening), Week 48 or end of study ] [ Designated as safety issue: Yes ]
  • Change from Screening Visit (Week -4) to Week 48 in Patient-Reported Absenteeism resulting from flu-like symptom (FLS) [ Time Frame: Week -4 (screening), Week 48 or end of study ] [ Designated as safety issue: Yes ]
  • Change from Baseline Visit (Day 1) to Week 48 in Participant Disability Status as Measured by the Patient Determined Disease Steps (PDDS) [ Time Frame: Day 1 (baseline, pre-dose), Week 48 or end of study ] [ Designated as safety issue: Yes ]
  • The number of Participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • The number of Participants that discontinue study treatment due to an Adverse Event (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 flu like symptoms (FLS) [ Time Frame: Weeks -4 to -1 (screening), Weeks 45-48 (last four weeks of study) ] [ Designated as safety issue: Yes ]
  • 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: Yes ]
  • The number of participants who test positive for Interferon-beta 1a neutralizing antibodies (IFN β-1a Nabs) [ Time Frame: Day 1 up to 48 Weeks ] [ Designated as safety issue: Yes ]
  • 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: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEGylated Interferon Beta-1a 125 μg plus current FLS therapy
125 μg PEGylated Interferon Beta-1a administered subcutaneously every 2 weeks for up to 48 weeks, plus current flu-like symptom (FLS) management or no FLS management.
Drug: BIIB017 (Peginterferon beta-1a)
125 μg PEGylated Interferon Beta-1a subcutaneous injection administration by participants or caregiver using a pre-filled pen every-2-weeks up to 48 weeks. There is an initial titration: initial dose is 63 μg followed two weeks later by a 94 μg dose. Once participants reach the 125 μg target dose at Week 4, they continue on this dose for the remainder of the study.
Other Name: PEG IFN β-1a
Experimental: PEGylated Interferon Beta-1a 125 μg plus Naproxen
125 ug PEGylated Interferon Beta-1a administered subcutaneously every 2 weeks for up to 48 weeks, plus 500 mg naproxen twice daily one day prior and two days post each PEGylated Interferon Beta-1a injection for 8 weeks, and as directed by the investigator after week 8.
Drug: BIIB017 (Peginterferon beta-1a)
125 μg PEGylated Interferon Beta-1a subcutaneous injection administration by participants or caregiver using a pre-filled pen every-2-weeks up to 48 weeks. There is an initial titration: initial dose is 63 μg followed two weeks later by a 94 μg dose. Once participants reach the 125 μg target dose at Week 4, they continue on this dose for the remainder of the study.
Other Name: PEG IFN β-1a
Drug: Naproxen
500 mg twice daily is administered before the PEGylated Interferon Beta-1a injection (up to 24 hours prior to treatment) and continuing for 48 hours following the PEGylated Interferon Beta-1a injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
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 BIIB017 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

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

  Show 39 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01939002     History of Changes
Other Study ID Numbers: 105MS303
Study First Received: August 23, 2013
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
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
Interferons
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

ClinicalTrials.gov processed this record on October 20, 2014