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

NCT01332019 | Completed Phase 3 Results DMC

• 2 other identifiers: 105MS3022010-024477-39
• Study Type: interventional
• Target: 1,077
• Locations: 25 countries
• Sites: 146

Brief 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.

Conditions

Relapsing Multiple Sclerosis

Keywords

Subcutaneous; Extension; Interferon; MS; PEGylated; Injectable; SC; PEG; peginterferon beta-1a; Relapsing

Outcome Measures

Primary Outcomes (5)

• Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs

  AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.

  up to 4 years

• Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities

  Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.

  up to 4 years

• Number of Participants With Shifts From Baseline: Liver Function Laboratory Values

  Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.

  Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

• Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry

  Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.

  Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

• Number of Participants With Shifts From Baseline: Urinalysis

  Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.

  Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

Secondary Outcomes (34)

• Annualized Relapse Rate (ARR)

  up to 4 years

• Percentage of Participants Who Relapsed

  Up to 4 years

• Number of New or Newly Enlarging T2 Hyperintense Lesions

  Week 48, Week 96

• Number of New Active Lesions

  Week 48, Week 96

• Number of New T1 Hypointense Lesions

  Week 48, Week 96

Study Arms (2)

peginterferon beta-1a Q4W

EXPERIMENTAL

125 µg peginterferon beta-1a administered by subcutaneous (SC) injection every 4 weeks (Q4W) for at least 2 years and up to 4 years.

Drug: peginterferon beta-1a

peginterferon beta-1a Q2W

EXPERIMENTAL

125 μg peginterferon beta-1a administered by SC injection every 2 weeks (Q2W) for at least 2 years and up to 4 years.

Drug: peginterferon beta-1a

Interventions

peginterferon beta-1a DRUG

Administered as specified in the treatment arm

Also known as: PEGylated Interferon beta-1a, Plegridy, PEG IFN β-1a, BIIB017

peginterferon beta-1a Q2W; peginterferon beta-1a Q4W

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 (NCT00906399).
• Subjects with any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease
• Pregnant or nursing women.

Sponsors & Collaborators

• Biogen: lead

Study Sites (151)

Research Site

Atlanta, Georgia, 30327, United States

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Lexington, Kentucky, 40513, United States

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Baltimore, Maryland, 21287, United States

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Raleigh, North Carolina, 27607 6520, United States

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Akron, Ohio, 44320, United States

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Cleveland, Ohio, 44195, United States

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Franklin, Tennessee, 37205, United States

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Sint-Truiden, 3800, Belgium

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Plovdiv, 4002, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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London, Ontario, N6A 5A5, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Santiago, 8207257, Chile

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Barranquilla, Colombia

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Bogotá, Colombia

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Zagreb, Croatia

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Brno, 625 00, Czechia

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Havffov, 73601, Czechia

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Olomouc, 775 20, Czechia

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Ostrava, 708 52, Czechia

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Ostrava-Vitkovice, 703 00, Czechia

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Prague, 128 08, Czechia

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Prague, 150 06, Czechia

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Teplice, 415 29, Czechia

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Pärnu, EE 80010, Estonia

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Tallinn, EE 10617, Estonia

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Tartu, EE 51014, Estonia

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Amiens, 80054, France

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Bouches-du-Rhone, 13385, France

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Clermont-Ferrand, 63003, France

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Nice, 6002, France

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Tbilisi, 0112, Georgia

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Tbilisi, 112, Georgia

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Tbilisi, 179, Georgia

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Tbilisi, 186, Georgia

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Bayreuth, 95445, Germany

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Berlin, 10713, Germany

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Cologne, 50935, Germany

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Erbach im Odenwald, 64711, Germany

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Hanover, 30559, Germany

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Leipzig, 4103, Germany

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Marberg, 35043, Germany

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Prien am Chiemsee, 83209, Germany

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Ulm, 89079, Germany

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Westerstede, 26655, Germany

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Athens, 11521, Greece

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Athens, 11525, Greece

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Thessaloniki, 57010, Greece

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Ahmedabad, Gujarat, 380006, India

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Rajkot, Gujarat, 360001, India

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Indore, Madhyr Pradesh, 452018, India

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Mumbai, Maharashtra, 400026, India

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Nagpur, Maharashtra, 440010, India

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Pune, Maharashtra, 411004, India

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Pune, Maharashtra, 411030, India

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Amritsar, Punjab, 143001, India

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Coimbatore, Tamil Nadu, 641014, India

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Kolkata, West Bengal, 700068, India

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Bangalore, 560017, India

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Chennai, 600017, India

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Mangalore, 575018, India

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Navi Mumbai, 400703, India

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New Delhi, 110029, India

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New Delhi, 110060, India

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Saket, 110017, India

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Riga, LV1005, Latvia

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Aguascalientes, 20127, Mexico

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Chihuahua City, 31203, Mexico

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Héroes de Padierna, 10700, Mexico

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Mexico City, 3600, Mexico

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Monterrey, 64710, Mexico

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Breda, 4818 CK, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Auckland, New Zealand

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Christchurch, New Zealand

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Dunedin, New Zealand

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Lima, Lima01, Peru

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Lima, Lima1, Peru

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Lima, Lima21, Peru

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San Isidro, Lima27, Peru

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Bialystok, 15276, Poland

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Bialystok, 15402, Poland

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Bydgoszcz, 85618, Poland

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Gdansk, 80299, Poland

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Gdansk, 80803, Poland

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Gdansk, 80952, Poland

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Gmina Końskie, 26200, Poland

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Katowice, 40594, Poland

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Katowice, 40662, Poland

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Katowice, 40749, Poland

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Katowice, 40752, Poland

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Krakow, 31505, Poland

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Krakow, 31637, Poland

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Krakow, 31826, Poland

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Lodz, 90153, Poland

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Lublin, 20718, Poland

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Lublin, 20954, Poland

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Olsztyn, 10082, Poland

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Plewiska, 62064, Poland

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Poznan, 60355, Poland

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Poznan, 61289, Poland

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Szczecin, 70111, Poland

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Szczecin, 71252, Poland

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Warsaw, 00851, Poland

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Warsaw, 04141, Poland

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Warsaw, 04749, Poland

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Wroclaw, 50556, Poland

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Brasov, 500123, Romania

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Bucharest, 50098, Romania

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Campulung Muscel, 115100, Romania

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Sibiu, 550166, Romania

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Târgu Mureş, 540136, Romania

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Kaluga, 248007, Russia

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Kazan', 420021, Russia

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Kransodar, 350012, Russia

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Kursk, 305007, Russia

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Moscow, 107150, Russia

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Moscow, 119021, Russia

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Novosibirsk, 630007, Russia

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Perm, 614990, Russia

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Rostov-on-Don, Russia

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Smolensk, Russia

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Ufa, 450005, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Córdoba, 14008, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Málaga, 29010, Spain

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Seville, 41009, Spain

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Chernivtsi, 58018, Ukraine

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Dnipropetrovsk, 49027, Ukraine

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Donetsk, 83099, Ukraine

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Kharkiv, 61068, Ukraine

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Kharkiv, 61103, Ukraine

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Kyiv, 3110, Ukraine

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Kyiv, 4107, Ukraine

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Odesa, 65025, Ukraine

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Poltava, 26011, Ukraine

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Simferopol, 95017, Ukraine

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Ternopil, 46027, Ukraine

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Vinnytsia, 21005, Ukraine

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London, E11BB, United Kingdom

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Manchester, M68HD, United Kingdom

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Nottingham, NG72UH, United Kingdom

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Sheffield, S108JF, United Kingdom

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Related Publications (2)

• Arnold DL, Shang S, Dong Q, Meergans M, Naylor ML. Peginterferon beta-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord. 2018 Aug 28;11:1756286418795085. doi: 10.1177/1756286418795085. eCollection 2018.

  PMID: 30181780 DERIVED

• Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA. Single-use autoinjector for peginterferon-beta1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study. Expert Opin Drug Deliv. 2014 Nov;11(11):1713-20. doi: 10.1517/17425247.2014.944159. Epub 2014 Jul 29.

  PMID: 25073663 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

peginterferon beta-1a

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Biogen Study Medical Director
• Organization: Biogen

clinicaltrials@biogen.com

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 8, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 13, 2017
• Results First Posted: January 13, 2017

Record last verified: 2016-11

Locations

NL (2); BE (1); CZ (8); CA (2); SE (3); RU (11); LA (1); GB (4); BU (6); GR (3); IN (17); CO (2); RO (5); NZ (3); ES (3); UA (12); PL (27); FR (4); CR (1); GE (4); US (7); CL (1); DE (10); PE (4); ME (5)