ATTAIN
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Peginterferon beta-1a
Interferon alpha/beta receptor agonist
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs
up to 4 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB017 Q4W | 471 participants | 529 | |
| BIIB017 Q2W | 478 participants | 547 | |
| BIIB017 Q4W | 343 participants | 529 | |
| BIIB017 Q2W | 348 participants | 547 | |
| BIIB017 Q4W | 74 participants | 529 | |
| BIIB017 Q2W | 73 participants | 547 | |
| BIIB017 Q4W | 400 participants | 529 | |
| BIIB017 Q2W | 399 participants | 547 | |
| BIIB017 Q4W | 113 participants | 529 | |
| BIIB017 Q2W | 90 participants | 547 | |
| BIIB017 Q4W | 18 participants | 529 | |
| BIIB017 Q2W | 26 participants | 547 | |
| BIIB017 Q4W | 14 participants | 529 | |
| BIIB017 Q2W | 23 participants | 547 |
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
up to 4 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB017 Q4W | 28 participants | 528 | |
| BIIB017 Q2W | 86 participants | 547 | |
| BIIB017 Q4W | 13 participants | 528 | |
| BIIB017 Q2W | 4 participants | 547 | |
| BIIB017 Q4W | 41 participants | 528 | |
| BIIB017 Q2W | 62 participants | 547 | |
| BIIB017 Q4W | 2 participants | 528 | |
| BIIB017 Q2W | 7 participants | 547 | |
| BIIB017 Q4W | 0 participants | 528 | |
| BIIB017 Q2W | 0 participants | 547 | |
| BIIB017 Q4W | 8 participants | 528 | |
| BIIB017 Q2W | 16 participants | 547 | |
| BIIB017 Q4W | 31 participants | 528 | |
| BIIB017 Q2W | 84 participants | 547 | |
| BIIB017 Q4W | 18 participants | 528 | |
| BIIB017 Q2W | 5 participants | 547 | |
| BIIB017 Q4W | 8 participants | 528 | |
| BIIB017 Q2W | 15 participants | 547 | |
| BIIB017 Q4W | 31 participants | 528 | |
| BIIB017 Q2W | 83 participants | 547 | |
| BIIB017 Q4W | 18 participants | 528 | |
| BIIB017 Q2W | 5 participants | 547 | |
| BIIB017 Q4W | 1 participants | 528 | |
| BIIB017 Q2W | 7 participants | 547 | |
| BIIB017 Q4W | 0 participants | 528 | |
| BIIB017 Q2W | 0 participants | 547 | |
| BIIB017 Q4W | 33 participants | 528 | |
| BIIB017 Q2W | 35 participants | 547 | |
| BIIB017 Q4W | 3 participants | 528 | |
| BIIB017 Q2W | 11 participants | 547 | |
| BIIB017 Q4W | 2 participants | 528 | |
| BIIB017 Q2W | 2 participants | 547 |
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB017 Q4W | 3 participants | 529 | |
| BIIB017 Q2W | 3 participants | 547 | |
| BIIB017 Q4W | 119 participants | 529 | |
| BIIB017 Q2W | 153 participants | 547 | |
| BIIB017 Q4W | 10 participants | 529 | |
| BIIB017 Q2W | 8 participants | 547 | |
| BIIB017 Q4W | 75 participants | 529 | |
| BIIB017 Q2W | 110 participants | 547 | |
| BIIB017 Q4W | 94 participants | 529 | |
| BIIB017 Q2W | 76 participants | 547 | |
| BIIB017 Q4W | 22 participants | 529 | |
| BIIB017 Q2W | 16 participants | 547 | |
| BIIB017 Q4W | 16 participants | 529 | |
| BIIB017 Q2W | 6 participants | 547 | |
| BIIB017 Q4W | 73 participants | 529 | |
| BIIB017 Q2W | 97 participants | 547 | |
| BIIB017 Q4W | 4 participants | 529 | |
| BIIB017 Q2W | 5 participants | 547 | |
| BIIB017 Q4W | 28 participants | 529 | |
| BIIB017 Q2W | 26 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 0 participants | 547 | |
| BIIB017 Q4W | 18 participants | 529 | |
| BIIB017 Q2W | 30 participants | 547 |
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 1 participants | 547 | |
| BIIB017 Q4W | 16 participants | 529 | |
| BIIB017 Q2W | 20 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 1 participants | 547 | |
| BIIB017 Q4W | 15 participants | 529 | |
| BIIB017 Q2W | 8 participants | 547 | |
| BIIB017 Q4W | 49 participants | 529 | |
| BIIB017 Q2W | 64 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 0 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 3 participants | 547 | |
| BIIB017 Q4W | 39 participants | 529 | |
| BIIB017 Q2W | 46 participants | 547 | |
| BIIB017 Q4W | 13 participants | 529 | |
| BIIB017 Q2W | 21 participants | 547 | |
| BIIB017 Q4W | 17 participants | 529 | |
| BIIB017 Q2W | 20 participants | 547 | |
| BIIB017 Q4W | 1 participants | 529 | |
| BIIB017 Q2W | 2 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 3 participants | 547 | |
| BIIB017 Q4W | 54 participants | 529 | |
| BIIB017 Q2W | 51 participants | 547 | |
| BIIB017 Q4W | 304 participants | 529 | |
| BIIB017 Q2W | 311 participants | 547 | |
| BIIB017 Q4W | 47 participants | 529 | |
| BIIB017 Q2W | 30 participants | 547 | |
| BIIB017 Q4W | 37 participants | 529 | |
| BIIB017 Q2W | 55 participants | 547 |
Number of Participants With Shifts From Baseline: Urinalysis
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB017 Q4W | 2 participants | 529 | |
| BIIB017 Q2W | 1 participants | 547 | |
| BIIB017 Q4W | 13 participants | 529 | |
| BIIB017 Q2W | 3 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 0 participants | 547 | |
| BIIB017 Q4W | 6 participants | 529 | |
| BIIB017 Q2W | 4 participants | 547 | |
| BIIB017 Q4W | 33 participants | 529 | |
| BIIB017 Q2W | 36 participants | 547 | |
| BIIB017 Q4W | 159 participants | 529 | |
| BIIB017 Q2W | 167 participants | 547 | |
| BIIB017 Q4W | 28 participants | 529 | |
| BIIB017 Q2W | 25 participants | 547 | |
| BIIB017 Q4W | 64 participants | 529 | |
| BIIB017 Q2W | 73 participants | 547 | |
| BIIB017 Q4W | 270 participants | 529 | |
| BIIB017 Q2W | 277 participants | 547 | |
| BIIB017 Q4W | 110 participants | 529 | |
| BIIB017 Q2W | 106 participants | 547 | |
| BIIB017 Q4W | 116 participants | 529 | |
| BIIB017 Q2W | 130 participants | 547 | |
| BIIB017 Q4W | 0 participants | 529 | |
| BIIB017 Q2W | 1 participants | 547 | |
| BIIB017 Q4W | 84 participants | 529 | |
| BIIB017 Q2W | 94 participants | 547 | |
| BIIB017 Q4W | 7 participants | 529 | |
| BIIB017 Q2W | 13 participants | 547 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| BIIB017 Q4W | 529 | 114 (21.6%) | |
| BIIB017 Q2W | 547 | 91 (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
SafetyNumber of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
up to 4 years
SafetyNumber 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
RelapsesPercentage of Participants Who Relapsed
Up to 4 years
RelapsesNumber of New or Newly Enlarging T2 Hyperintense Lesions
Week 48, Week 96
MRI lesionsNumber of New Active Lesions
Week 48, Week 96
MRI lesionsNumber of New T1 Hypointense Lesions
Week 48, Week 96
MRI lesionsNumber of Gd-Enhancing Lesions
Baseline (start of 105MS302), Week 48, Week 96
MRI lesionsVolume of T2 Hyperintense Lesions
Baseline (start of 105MS302), Week 48, Week 96
MRI lesionsVolume of T1 Hypointense Lesions
Baseline (start of 105MS302), Week 48, Week 96
MRI lesionsVolume of Gd-Enhancing Lesions
Baseline (start of 105MS302), Week 48, Week 96
MRI lesionsPercentage 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
Results
Early treatment responses to peginterferon beta-1a are associated with longer-term clinical outcomes in patients with relapsing-remitting multiple sclerosis: Subgroup analyses of ADVANCE and ATTAIN.Mult Scler Relat Disord · 2022
Results
Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis.BMC Neurol · 2014
Results
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.Results
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.
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History
Started
Apr 2011
Main results due
Oct 2015
Finished
Oct 2015
Results posted
Jan 2017
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