Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02230969
Other study ID # 105MS401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 12, 2014
Est. completion date January 20, 2022

Study information

Verified date September 2022
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.


Recruitment information / eligibility

Status Completed
Enrollment 1208
Est. completion date January 20, 2022
Est. primary completion date January 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002). - Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance. Key Exclusion Criteria: - Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia Research Site Auchenflower Queensland
Australia Research Site Bedford Park South Australia
Australia Research Site Camperdown New South Wales
Australia Research Site Fitzroy Victoria
Australia Research Site Heidelberg Victoria
Australia Research Site New Lambton Heights New South Wales
Austria Research Site Linz
Austria Research Site Vienna
Canada Research Site Barrie Ontario
Canada Research Site Calgary Alberta
Canada Research Site Cambridge Ontario
Canada Research Site Gatineau Quebec
Canada Research Site Halifax Nova Scotia
Canada Research Site Saint John New Brunswick
Canada Research Site Sydney Nova Scotia
Canada Research Site Toronto Ontario
Denmark Research Site Esbjerg
Denmark Research site Glostrup
Denmark Research Site Sonderborg
France Research Site Gonesse
France Research Site La Seyne sur Mer Var
France Research Site Le Mans cedex 9 Sarthe
France Research Site Mantes La Jolie cedex Yvelines
France Research Site Montpellier Herault
France Research Site Nimes Gard
France Research Site Poitiers cedex Vienne
France Research Site Rennes cedex 09 Ille Et Vilaine
France Research Site Saint Malo cedex Ille Et Vilaine
France Research Site Toulouse cedex 9 Haute Garonne
Germany Research Site Aachen Nordrhein Westfalen
Germany Research Site Aalen Baden Wuerttemberg
Germany Research Site Altenburg Thueringen
Germany Research Site Bad Homburg Hessen
Germany Research Site Bamberg Bayern
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Bonn Nordrhein Westfalen
Germany Research Site Butzbach Hessen
Germany Research Site Chemnitz Sachsen
Germany Research Site Duesseldorf Nordrhein Westfalen
Germany Research Site Erfurt Thueringen
Germany Research Site Frankfurt Hessen
Germany Research Site Freiburg Baden Wuerttemberg
Germany Research Site Gelnhausen Hessen
Germany Research Site Gottingen Niedersachsen
Germany Research Site Hamburg
Germany Research Site Hamburg
Germany Research Site Heidenheim Baden Wuerttemberg
Germany Research Site Itzehoe Schleswig Holstein
Germany Research Site Jena Thueringen
Germany Research Site Kandel Rheinland Pfalz
Germany Research Site Kassel Hessen
Germany Research Site Kiel Schleswig Holstein
Germany Research Site Koeln Nordrhein Westfalen
Germany Research Site Ladenburg Baden Wuerttemberg
Germany Research Site Leipzig Sachsen
Germany Research Site Ludwigshafen Rheinland Pfalz
Germany Research Site Muenchen Bayern
Germany Research Site Pforzheim Baden Wuerttemberg
Germany Research Site Regensburg Bayern
Germany Research Site Regensburg Bayern
Germany Research Site Ruedersdorf Brandenburg
Germany Research Site Sande Niedersachsen
Germany Research Site Siegen Nordrhein Westfalen
Germany Research Site Stade Niedersachsen
Germany Research Site Stadtroda Thueringen
Germany Research Site Stuttgart Baden Wuerttemberg
Ireland Research Site Dublin
Italy Research Site Bergamo
Italy Research Site Cagliari
Italy Research Site Catanzaro
Italy Research Site Firenze
Italy Research Site Genova
Italy Research Site Messina
Italy Research Site Milano
Italy Research Site Napoli
Italy Research Site Roma
Italy Research Site Roma
Italy Research Site Roma
Netherlands Research Site Blaricum
Netherlands Research Site Breda
Netherlands Research Site Hoorn
Portugal Research Site Guimarães
Portugal Research Site Setúbal
Spain Research Site Cadiz
Spain Research Site Cordoba
Spain Research Site Málaga
Spain Research Site Sevilla
Spain Research Site Sevilla
Switzerland Research Site Aarau
Switzerland Research Site Basel
Switzerland Research Site Bern
Switzerland Research Site Luzern
United Kingdom Research Site Glasgow Strathclyde
United Kingdom Research Site Inverness Highland Region
United Kingdom Research Site Irvine Ayrshire
United Kingdom Research Site Leicester Leicestershire
United Kingdom Research Site London Greater London
United Kingdom Research Site Salford Greater Manchester
United Kingdom Research Site Swansea
United Kingdom Research Site Truro Cornwall
United States Research Site Albuquerque New Mexico
United States Research Site Atlanta Georgia
United States Research Site Basalt Colorado
United States Research Site Bedford Texas
United States Research Site Berkeley California
United States Research Site Boston Massachusetts
United States Research Site Buffalo New York
United States Research Site California City California
United States Research Site Charlotte North Carolina
United States Research Site Colorado Springs Colorado
United States Research Site Dayton Ohio
United States Research Site Dayton Ohio
United States Research Site Delray Beach Florida
United States Research Site Des Moines Iowa
United States Research Site Freehold New Jersey
United States Research Site Gilbert Arizona
United States Research Site Golden Valley Minnesota
United States Research Site Great Falls Montana
United States Research Site Hanford California
United States Research Site Hickory North Carolina
United States Research Site Homewood Alabama
United States Research Site Indianapolis Indiana
United States Research Site Iowa City Iowa
United States Research Site Knoxville Tennessee
United States Research Site Lebanon New Hampshire
United States Research Site Lexington Massachusetts
United States Research Site Louisville Kentucky
United States Research Site Milwaukee Wisconsin
United States Research Site New Hyde Park New York
United States Research Site New Orleans Louisiana
United States Research Site New York New York
United States Research Site Oklahoma City Oklahoma
United States Research Site Oklahoma City Oklahoma
United States Research Site Orange California
United States Research Site Pittsburgh Pennsylvania
United States Research Site Port Royal South Carolina
United States Research Site Portland Oregon
United States Research Site Raleigh North Carolina
United States Research Site Richmond Virginia
United States Research Site Saint Louis Missouri
United States Research Site Salt Lake City Utah
United States Research Site Scarborough Maine
United States Research Site Schaumburg Illinois
United States Research Site Scottsdale Arizona
United States Research Site Southfield Michigan
United States Research Site Staten Island New York
United States Research Site Virginia Beach Virginia
United States Research Site Washington District of Columbia
United States Research Site Washington District of Columbia
United States Research Site Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Denmark,  France,  Germany,  Ireland,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as measured by the incidence proportion of SAEs Up to 5 years
Primary Safety as measured by the incidence rate of SAEs Up to 5 years
Primary Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses Up to 5 years
Primary Clinical NEDA as measured by the proportion of participants with no disability progression Up to 5 years
Secondary Prescription and utilization patterns as measured by prescribed dosing frequency Up to 5 years
Secondary Prescription and utilization patterns as measured by duration of Plegridy use Up to 5 years
Secondary Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy Up to 5 years
Secondary Relapse activity as measured by annualized relapse rate (ARR) Up to 5 years
Secondary Relapse activity as measured by time to first relapse Up to 5 years
Secondary Relapse activity as measured by the proportion of participants with relapse Up to 5 years
Secondary Relapse activity as measured by the distribution of the number of relapses Up to 5 years
Secondary Disability progression as measured by the proportion of participants with sustained progression for at least six months Disability progression measured by the Expanded Disability Status Scale (EDSS). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of = 1 point from baseline system score of = 1 or an increase of = 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of = 2 points from baseline system score of = 1 or an increase of = 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later. Up to 5 years
Secondary Disability progression as measured by the time to sustained disability progression for at least six months Up to 5 years
Secondary Incidence proportion of non-serious AEs leading to treatment discontinuation Up to 5 years
Secondary Incidence rate of non-serious AEs leading to treatment discontinuation Up to 5 years
Secondary Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS Up to 5 years
Secondary Changes in FLS assessment and FLS-VAS over time Baseline to 5 years
Secondary Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Baseline to 5 years
Secondary Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires Where pen/syringe collection is locally allowed, treatment adherence will also be assessed by the proportion of used auto-injector pens/pre-filled syringes out of the total number of pens/syringes prescribed. Baseline to 5 years
Secondary Frequency of MS-related and non-MS-related physician visits, specialists' visits, use of physiotherapy, hospitalizations and lengths of stay, and emergency room/department visits Up to 5 years
See also
  Status Clinical Trial Phase
Completed NCT01201356 - Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis Phase 3
Suspended NCT04909502 - Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis Phase 2
Recruiting NCT05083923 - A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS) Phase 3
Withdrawn NCT02428218 - Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Phase 3
Completed NCT01873417 - Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States Phase 4
Completed NCT04676555 - Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis
Recruiting NCT05798520 - A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis Phase 2
Completed NCT00424788 - A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS) Phase 0
Recruiting NCT06251986 - A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice
Completed NCT02097849 - Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis. Phase 2
Completed NCT01903291 - Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS N/A
Completed NCT01216072 - A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis Phase 4