CompletedPhase 3Relapsing MSNCT013320192010-024477-39

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

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

up to 4 years

GroupValueIntervalNumber analysed
BIIB017 Q4W471 participants529
BIIB017 Q2W478 participants547
BIIB017 Q4W343 participants529
BIIB017 Q2W348 participants547
BIIB017 Q4W74 participants529
BIIB017 Q2W73 participants547
BIIB017 Q4W400 participants529
BIIB017 Q2W399 participants547
BIIB017 Q4W113 participants529
BIIB017 Q2W90 participants547
BIIB017 Q4W18 participants529
BIIB017 Q2W26 participants547
BIIB017 Q4W14 participants529
BIIB017 Q2W23 participants547

Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities

up to 4 years

GroupValueIntervalNumber analysed
BIIB017 Q4W28 participants528
BIIB017 Q2W86 participants547
BIIB017 Q4W13 participants528
BIIB017 Q2W4 participants547
BIIB017 Q4W41 participants528
BIIB017 Q2W62 participants547
BIIB017 Q4W2 participants528
BIIB017 Q2W7 participants547
BIIB017 Q4W0 participants528
BIIB017 Q2W0 participants547
BIIB017 Q4W8 participants528
BIIB017 Q2W16 participants547
BIIB017 Q4W31 participants528
BIIB017 Q2W84 participants547
BIIB017 Q4W18 participants528
BIIB017 Q2W5 participants547
BIIB017 Q4W8 participants528
BIIB017 Q2W15 participants547
BIIB017 Q4W31 participants528
BIIB017 Q2W83 participants547
BIIB017 Q4W18 participants528
BIIB017 Q2W5 participants547
BIIB017 Q4W1 participants528
BIIB017 Q2W7 participants547
BIIB017 Q4W0 participants528
BIIB017 Q2W0 participants547
BIIB017 Q4W33 participants528
BIIB017 Q2W35 participants547
BIIB017 Q4W3 participants528
BIIB017 Q2W11 participants547
BIIB017 Q4W2 participants528
BIIB017 Q2W2 participants547

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

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

GroupValueIntervalNumber analysed
BIIB017 Q4W3 participants529
BIIB017 Q2W3 participants547
BIIB017 Q4W119 participants529
BIIB017 Q2W153 participants547
BIIB017 Q4W10 participants529
BIIB017 Q2W8 participants547
BIIB017 Q4W75 participants529
BIIB017 Q2W110 participants547
BIIB017 Q4W94 participants529
BIIB017 Q2W76 participants547
BIIB017 Q4W22 participants529
BIIB017 Q2W16 participants547
BIIB017 Q4W16 participants529
BIIB017 Q2W6 participants547
BIIB017 Q4W73 participants529
BIIB017 Q2W97 participants547
BIIB017 Q4W4 participants529
BIIB017 Q2W5 participants547
BIIB017 Q4W28 participants529
BIIB017 Q2W26 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W0 participants547
BIIB017 Q4W18 participants529
BIIB017 Q2W30 participants547

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

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

GroupValueIntervalNumber analysed
BIIB017 Q4W0 participants529
BIIB017 Q2W1 participants547
BIIB017 Q4W16 participants529
BIIB017 Q2W20 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W1 participants547
BIIB017 Q4W15 participants529
BIIB017 Q2W8 participants547
BIIB017 Q4W49 participants529
BIIB017 Q2W64 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W0 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W3 participants547
BIIB017 Q4W39 participants529
BIIB017 Q2W46 participants547
BIIB017 Q4W13 participants529
BIIB017 Q2W21 participants547
BIIB017 Q4W17 participants529
BIIB017 Q2W20 participants547
BIIB017 Q4W1 participants529
BIIB017 Q2W2 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W3 participants547
BIIB017 Q4W54 participants529
BIIB017 Q2W51 participants547
BIIB017 Q4W304 participants529
BIIB017 Q2W311 participants547
BIIB017 Q4W47 participants529
BIIB017 Q2W30 participants547
BIIB017 Q4W37 participants529
BIIB017 Q2W55 participants547

Number of Participants With Shifts From Baseline: Urinalysis

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

GroupValueIntervalNumber analysed
BIIB017 Q4W2 participants529
BIIB017 Q2W1 participants547
BIIB017 Q4W13 participants529
BIIB017 Q2W3 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W0 participants547
BIIB017 Q4W6 participants529
BIIB017 Q2W4 participants547
BIIB017 Q4W33 participants529
BIIB017 Q2W36 participants547
BIIB017 Q4W159 participants529
BIIB017 Q2W167 participants547
BIIB017 Q4W28 participants529
BIIB017 Q2W25 participants547
BIIB017 Q4W64 participants529
BIIB017 Q2W73 participants547
BIIB017 Q4W270 participants529
BIIB017 Q2W277 participants547
BIIB017 Q4W110 participants529
BIIB017 Q2W106 participants547
BIIB017 Q4W116 participants529
BIIB017 Q2W130 participants547
BIIB017 Q4W0 participants529
BIIB017 Q2W1 participants547
BIIB017 Q4W84 participants529
BIIB017 Q2W94 participants547
BIIB017 Q4W7 participants529
BIIB017 Q2W13 participants547

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
BIIB017 Q4W529114 (21.6%)
BIIB017 Q2W54791 (16.6%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    up to 4 years

    Safety
  • Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities

    up to 4 years

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

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

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

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

  • Number of Participants With Shifts From Baseline: Urinalysis

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

  • The primary endpoints include the incidence of AEs, serious AEs (SAEs), and discontinuations of study treatment due to an AE, as well as the incidence of laboratory abnormalities.

    Safety

Other measures (35)

  • Annualized Relapse Rate (ARR)

    up to 4 years

    Relapses
  • Percentage of Participants Who Relapsed

    Up to 4 years

    Relapses
  • Number of New or Newly Enlarging T2 Hyperintense Lesions

    Week 48, Week 96

    MRI lesions
  • Number of New Active Lesions

    Week 48, Week 96

    MRI lesions
  • Number of New T1 Hypointense Lesions

    Week 48, Week 96

    MRI lesions
  • Number of Gd-Enhancing Lesions

    Baseline (start of 105MS302), Week 48, Week 96

    MRI lesions
  • Volume of T2 Hyperintense Lesions

    Baseline (start of 105MS302), Week 48, Week 96

    MRI lesions
  • Volume of T1 Hypointense Lesions

    Baseline (start of 105MS302), Week 48, Week 96

    MRI lesions
  • Volume of Gd-Enhancing Lesions

    Baseline (start of 105MS302), Week 48, Week 96

    MRI lesions
  • Percentage Change of Whole Brain Volume

    Baseline (start of 105MS302), Week 48, Week 96

    MRI lesionsBrain volume loss

Who could take part

Relapsing MS · 18 to 65

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Linked trials

  • Referred to by

    POP

    Completed

  • Extension of

    ADVANCE

    Phase 3 · Completed

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Apr 2011

    2. Main results due

      Oct 2015

    3. Finished

      Oct 2015

    4. Results posted

      Jan 2017

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