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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01332019
Other study ID # 105MS302
Secondary ID 2010-024477-39
Status Completed
Phase Phase 3
First received March 24, 2011
Last updated August 9, 2016
Start date April 2011
Est. completion date October 2015

Study information

Verified date August 2016
Source Biogen
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPBulgaria: Bulgarian Drug AgencyCanada: Health CanadaChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCroatia: Agency for Medicinal Product and Medical DevicesCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareIndia: Central Drugs Standard Control OrganizationLatvia: State Agency of MedicinesMexico: Secretaria de SaludNetherlands: Medicines Evaluation Board (MEB)New Zealand: Ministry of HealthPeru: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Agency for Medicines and Medical DevicesRussia: Ministry of Health of the Russian FederationSerbia: Medicines and Medical Devices AgencySpain: Agencia Española de Medicamentos y Productos SanitariosUkraine: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.


Recruitment information / eligibility

Status Completed
Enrollment 1077
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria:

- Must have completed the study treatment and visit schedule through Week 96 in Study 105MS301 (NCT00906399).

Key Exclusion Criteria:

- Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 (NCT00906399).

- Subjects with any clinically significant lab abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease

- Pregnant or nursing women.

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Belgium Research Site Sint-Truiden
Bulgaria Research Site Plovdiv
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Canada Research Site London Ontario
Canada Research Site Montreal
Chile Research Site Santiago
Colombia Research Site Barranquilla
Colombia Research Site Bogota
Colombia Research Site Bogota
Croatia Research Site Zagreb
Czech Republic Research Site Brno
Czech Republic Research Site Havffov
Czech Republic Research Site Olomouc
Czech Republic Research Site Ostrava - Vitkovice
Czech Republic Research Site Praha 2
Czech Republic Research Site Praha 5
Czech Republic Research Site Teplice
Estonia Research Site Parnu
Estonia Research Site Tallinn
Estonia Research Site Tartu
France Research Site Amiens
France Research Site Bat H - BP 1069 Cice cedex 1, Alpes Maritimes
France Research Site Bouches-du-Rhone Marseille cedex 5
France Research Site Clermont-Ferrand
Georgia Research Site Tbilisi
Georgia Research Site Tbilisi
Georgia Research Site Tbilisi
Germany Research Site Bayern
Germany Research Site Berlin
Germany Research Site Erbach Hessen
Germany Research Site Hannover Niedersachsen
Germany Research Site Hessen
Germany Research Site Koln
Germany Research Site Leipzig
Germany Research Site Niedersachsen
Germany Research Site Prien
Germany Research Site Ulm
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Thessaloniki
India Research Site Ahmedabad Gujarat
India Research Site Ansari Nagur. New Delhi
India Research Site Chennai Tamil Nadu
India Research Site Coimbatore Tamil Nadu
India Research Site Indore Madhya Pradesh
India Research Site Indore
India Research Site Kolkata West Bengal
India Research Site Mangalore
India Research Site Mumbai Maharashtra
India Research Site Nagpur Maharashtra
India Research Site Nasik Maharashtra
India Research Site Navi Mumbai
India Research Site New Delhi Nehru Nagar
India Research Site New Delhi Delhi
India Research Site Pune Maharashtra
India Research Site Pune Maharashtra
India Research Site Punjab
India Research Site Rajkot
India Research Site Saket
India Research Site T. Nagar Chennai
Latvia Research Site Riga
Mexico Research Site Aquas Calientes
Mexico Research Site Chihuahua
Mexico Research Site Col Heroes de Padierna
Mexico Research Site Mexico City
Mexico Research Site Monterrey
Netherlands Research Site Breda
Netherlands Research Site Nieuwegein
New Zealand Research Site Auckland
New Zealand Research Site Christchurch
New Zealand Research Site Dunedin
Peru Research Site Lima Lima 1
Peru Research Site Lima Lima 27
Peru Research Site Lima
Peru Research Site Lima
Poland Research Site Bialystok
Poland Research Site Bialystok
Poland Research Site Bydgoszcz
Poland Research Site Gdansk
Poland Research Site Gdansk
Poland Research Site Gdansk
Poland Research Site Katowice
Poland Research Site Katowice
Poland Research Site Katowice
Poland Research Site Katowice
Poland Research Site Konskie
Poland Research Site Krakow
Poland Research Site Krakow
Poland Research Site Krakow
Poland Research Site Lodz
Poland Research Site Lublin
Poland Research Site Lublin
Poland Research Site Olsztyn
Poland Research Site Plewiska
Poland Research Site Poznan
Poland Research Site Poznan
Poland Research Site Szczecin
Poland Research Site Szczecin
Poland Research Site Warszawa
Poland Research Site Warszawa
Poland Research Site Warszawa
Poland Research Site Wroclaw
Romania Research Site Brasov
Romania Research Site Bucuresti
Romania Research Site Campulung
Romania Research Site Sibiu
Romania Research Site Targu Mures
Russian Federation Research Site Kaluga
Russian Federation Research Site Kazan
Russian Federation Research Site Kuvatov
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Perm
Russian Federation Research Site Rostov-on-Don
Russian Federation Research Site Smolensk
Russian Federation Research Site Sumskaya Str Kursk
Russian Federation Research Site Ufa
Russian Federation Research Site Ulitsa Krasnykh Partizan, 6
Serbia Research Site Belgrade
Serbia Research Site Kragujevac
Serbia Research Site Nis
Spain Research Site Cordoba
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Seville
Ukraine Research Site Chernivtsi
Ukraine Research Site Dnipropetrovsk
Ukraine Research Site Donetsk
Ukraine Research Site Kharkiv
Ukraine Research Site Kharkiv
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Odesa
Ukraine Research Site Poltava
Ukraine Research Site Simferopol
Ukraine Research Site Ternopil
Ukraine Research Site Vinnytsya
United Kingdom Research Site Greater Manchester,
United Kingdom Research Site London Greater London
United Kingdom Research Site Nottingham Nottinghamshire
United Kingdom Research Site West Midlands
United States Research Site Akron Ohio
United States Research Site Atlanta Georgia
United States Research Site Baltimore Maryland
United States Research Site Cleveland Ohio
United States Research Site Lexington Kentucky
United States Research Site Nashville Tennessee
United States Research Site Raleigh North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czech Republic,  Estonia,  France,  Georgia,  Germany,  Greece,  India,  Latvia,  Mexico,  Netherlands,  New Zealand,  Peru,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants experiencing adverse events 2 years Yes
Primary Number of participants experiencing serious adverse events 2 years Yes
Secondary Annualized relapse rate (ARR) Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The relapse rate for each treatment group will be calculated as the total number of relapses experienced in the group divided by the total number of days in the study for the group, and the ratio multiplied by 365. 2 years No
Secondary Percentage of participants who relapse New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse are considered part of the same relapse. 2 years No
Secondary The total number of new or newly enlarging T2 hyperintense lesions as assessed by magnetic resonance imaging (MRI) 2 years No
Secondary The number of new active lesions as assessed by MRI 2 years No
Secondary The total number of new T1 hypointense lesions as assessed by MRI 2 years No
Secondary The number of Gadolinium (Gd)-enhancing lesions as assessed by MRI 2 years No
Secondary The volume of T2 hyperintense lesions as assessed by MRI 2 years No
Secondary The volume of T1 hypointense lesions as assessed by MRI 2 years No
Secondary The volume of Gd-enhancing lesions as assessed by MRI 2 years No
Secondary Percent change of whole brain atrophy as assessed by MRI 2 years No
Secondary Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS) Expanded Disability Status Scale (EDSS) from baseline EDSS = 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Baseline and 2 years No
Secondary Time to sustained progression of disability Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS = 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS 2 years No
Secondary Cognitive function as reflected by the Symbol Digit Modalities Test (SDMT) SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). 2 years No
Secondary Change from Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 physical score The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. 2 years No
Secondary Change from Baseline in 12-Item Short Form Health Survey (SF-12) The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health. 2 years No
Secondary Change form Baseline in Euro Quality of Life (EQ-5D) The EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety). 2 years No
Secondary The number of relapses requiring intravenous (IV) steroid use 2 years No
Secondary The number of MS-related hospitalizations 2 years No
Secondary Percent of participant-reported treatment satisfaction Participants will complete the Treatment Satisfaction Questionnaire: This questionnaire is composed of a range of questions regarding the participant's perception of treatment satisfaction. 2 years No
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