Long-Term Safety and Efficacy Study of Peginterferon Beta-1a

Relapsing Multiple Sclerosis Clinical Trial

— ATTAIN  

Official title:

A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

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