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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— ALLOW  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939002
• Other study ID #: 105MS303
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2013
• Last updated: August 10, 2016
• Start date: November 2013
• Est. completion date: November 2015

Study information

• Verified date: August 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-ß and must be receiving a stable dose of IFN-ß 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• peginterferon beta-1a
Administered as specified in the treatment arm
• naproxen
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Research Site	Akron	Ohio
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boulder	Colorado
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Dayton	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Dover	Delaware
United States	Research Site	Fort Collins	Colorado
United States	Research Site	Franklin	Tennessee
United States	Research Site	Gilbert	Arizona
United States	Research Site	Great Falls	Montana
United States	Research Site	Greenville	South Carolina
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kansas City	Kansas
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Latham	New York
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lexington	Massachusetts
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Louisville	Kentucky
United States	Research Site	Melbourne	Florida
United States	Research Site	Newark	Delaware
United States	Research Site	Newport News	Virginia
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Phoenix	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plainview	New York
United States	Research Site	Portland	Oregon
United States	Research Site	Roanoke	Virginia
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Spokane	Washington
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tampa	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Uniontown	Ohio
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Experiencing New or Increased FLS as Measured by the Total FLS-S	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.	Day 1 up to 48 weeks	Yes
Secondary	Frequency and severity of FLS measured by FLS-S		Day 1 up to 48 Weeks	No
Secondary	Duration of FLS		Day 1 up to 48 weeks	No
Secondary	Proportion of participants who experience FLS during the first 8 weeks		Day 1 up to 48 weeks	No
Secondary	Severity and frequency of FLS as measured by FLS-S during the first 8 weeks		Day 1 up to 8 Weeks	No
Secondary	Duration of each FLS during the first 8 weeks		Day 1 up to 8 Weeks	No
Secondary	Percentage of participants who need additional FLS management regimen to relieve peginterferon beta-1a- related FLS		Day 1 up to 48 Weeks	No
Secondary	Change from Screening Visit (Week -4) to Week 48 in Patient-Reported treatment satisfaction as measured with the TSQM	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.	Week -4 (screening), Week 48 or end of study	No
Secondary	Change from Screening Visit (Week -4) to Week 48 in Participant-Reported Absenteeism resulting from FLS		Week -4 (screening), Week 48 or end of study	No
Secondary	Change from Baseline Visit (Day 1) to Week 48 in Participant Disability Status as Measured by PDDS	PDDS is a self-report questionnaire that contains a single item for measuring self-reported disability using an 8-level ordinal scale.	Day 1 (baseline, pre-dose), Week 48 or end of study	No
Secondary	The number of Participants that experience AEs and Serious Adverse Events (SAEs)		Up to week 52	Yes
Secondary	The number of Participants that discontinue study treatment due to an AE		Up to week 52	Yes
Secondary	Change from Screening (Weeks -4 to -1) to the last four weeks of study (Weeks 45-48) in Duration of FLS		Weeks -4 to -1 (screening), Weeks 45-48 (last four weeks of study)	No
Secondary	The number of participants who test positive for Interferon-beta 1a binding antibodies (IFN ß-1a BAbs)		Day 1 up to 48 Weeks	No
Secondary	The number of participants who test positive for IFN ß-1a Nabs		Day 1 up to 48 Weeks	No
Secondary	The number of participants who test positive for Interferon-beta 1a anti-PEG antibodies		Day 1 up to 48 Weeks	No
Secondary	Effectiveness and participants' satisfaction with FLS management as measured by FLS-VAS		Day 1 up to 48 weeks	No