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

Biogen

Status and phase: Completed; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: peginterferon beta-1a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332019

105MS302

2010-024477-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,077 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 laboratory 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,077 participants in 2 patient groups

peginterferon beta-1a Q4W

Experimental group

Description:

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

Treatment:

Drug: peginterferon beta-1a

peginterferon beta-1a Q2W

Experimental group

Description:

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

Treatment:

Drug: peginterferon beta-1a