BIIB017 Related Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients (ALLOW)

This study is currently recruiting participants.
Verified February 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01939002
First received: August 23, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

The primary objective of this study is to determine the proportion of relapsing multiple sclerosis (RMS) patients who experience new and/or increased flu-like symptoms (FLS) transitioning from nonpegylated interferon beta (IFN-β) therapies to BIIB017. Secondary objectives of this study in this study population are: to determine the severity and frequency (measured by flu-like symptom score [FLS-S]) of FLS in these subjects; to determine the duration (measured in number of hours) of FLS in these subjects; to determine the effect of BIIB017 on other patient 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 patients switching from prior IFN-β therapy to BIIB017.


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

Study Type: Interventional
Study Design: Allocation: 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 patients experiencing FLS (defined as an increase of ≥2.0 in total FLS-S) after transitioning from nonpegylated IFN therapies to BIIB017. [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency and severity of flu-like symptoms (FLS) (measured by flu-like symptom score [FLS-S]). [ Time Frame: Up to 48 Weeks ] [ Designated as safety issue: Yes ]
  • Duration of flu-like symptoms (FLS) (measured by number of hours). [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects in each randomized arm who experience flu-like symptoms (FLS) during the first 8 weeks after transitioning from nonpegylated interferon (IFN) therapies to BIIB017 [ Time Frame: 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) [ Time Frame: during the first 8 weeks after transitioning from nonpegylated IFN therapies to BIIB017 ] [ Designated as safety issue: Yes ]
  • Duration of each flu-like symptom (FLS) as measured by number of hours [ Time Frame: during the first 8 weeks after transitioning from nonpegylated IFN therapies to BIIB017 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects who need additional flu-like symptoms (FLS) management regimen to relieve BIIB017-related FLS [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Patient-reported treatment satisfaction as measured with the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in patient-reported absenteeism resulting from flu-like symptom (FLS) compared with previous nonpegylated IFN-β treatment [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Patient disability status as measured by the Patient Determined Disease Steps (PDDS) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • The number of subjects that experience Adverse Events (AEs) and Serious Advers Events (SAEs) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • The number of subjects that discontinue study treatment due to an Adverse Event (AE) [ Time Frame: Up to week 52 ] [ Designated as safety issue: Yes ]
  • Duration of flu like symptoms (FLS) [ Time Frame: within screening period compared with the last 4 weeks of the treatment period ] [ Designated as safety issue: Yes ]
  • The number of subjects that test positive for Interferon-beta 1a binding antibodies (IFN β-1a BAbs) [ Time Frame: Up to week 48 ] [ Designated as safety issue: Yes ]
  • The number of subjects that test positive for Interferon-beta 1a neutralizing antibodies (IFN β-1a Nabs) [ Time Frame: Up to week 48 ] [ Designated as safety issue: Yes ]
  • The number of subjects that test positive for Interferon-beta 1a anti-PEG antibodies [ Time Frame: Up to week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginterferon beta-1a 125 μg
125 μg Peginterferon beta-1a will be administered subcutaneously every 2 weeks plus current FLS management or no FLS management
Biological: Peginterferon beta-1a
125 μg Peginterferon beta-1a will be administered by a subcutaneous (SC) injection via a pre-filled pen every-2-weeks after an initial 4-week titration period
Other Name: BIIB017
Experimental: Peginterferon beta-1a 125 μg plus Naproxen
125 ug Peginterferon beta-1a administered subcutaneously every 2 weeks plus 500 mg naproxen twice daily
Biological: Peginterferon beta-1a
125 μg Peginterferon beta-1a will be administered by a subcutaneous (SC) injection via a pre-filled pen every-2-weeks after an initial 4-week titration period
Other Name: BIIB017
Drug: naproxen
500 mg twice daily is administered before their BIIB017 injection (up to 24 hours prior to treatment) and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

  Eligibility

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

Inclusion Criteria:

  • Must have a confirmed diagnosis of relapsing forms of MS, as defined by McDonald criteria #1-4 [Polman 2005].
  • Must have an EDSS score between 0.0 and 5.0.
  • Must have been treated with IFN-β and must be receiving treatment with stable dose of IFN 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.

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.
  • 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 randomization and/or lack of stabilization from a previous relapse prior to randomization (Day 1).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01939002

Contacts
Contact: Medical Director neurologyclinicaltrials@biogenidec.com

  Show 27 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: February 7, 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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014