Phase 3
Completed N=1,077
Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
Source: ClinicalTrials.gov NCT01332019 ↗Enrolled (actual)
1,077
Serious AEs
19.1%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs — 471; 478; 343; 348 participants
◆ Published Evidence
Emerging
12citations · ~1 / year
Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.
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.
Linked Publications (2)
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Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.
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Peginterferon β-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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs |
471; 478; 343; 348; 74; 73 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities |
28; 86; 13; 4; 41; 62 | — |
| PRIMARY Number of Participants With Shifts From Baseline: Liver Function Laboratory Values |
3; 3; 119; 153; 10; 8 | — |
| PRIMARY Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry |
0; 1; 16; 20; 0; 1 | — |
| PRIMARY Number of Participants With Shifts From Baseline: Urinalysis |
2; 1; 13; 3; 0; 0 | — |
| SECONDARY Annualized Relapse Rate (ARR) |
0.189; 0.142 | 0.0203 sig |
| SECONDARY Percentage of Participants Who Relapsed |
71; 77; 29; 23 | 0.0201 sig |
| SECONDARY Number of New or Newly Enlarging T2 Hyperintense Lesions |
4.4; 1.9; 8.9; 3.9 | <0.0001 sig |
| SECONDARY Number of New Active Lesions |
4.4; 2.0; 9.0; 3.9 | <0.0001 sig |
| SECONDARY Number of New T1 Hypointense Lesions |
1.4; 0.8; 2.8; 1.5 | <0.0001 sig |
| SECONDARY Number of Gd-Enhancing Lesions |
0.6; 0.2; 0.7; 0.2; 0.8; 0.2 | 0.0012 sig |
| SECONDARY Volume of T2 Hyperintense Lesions |
11.4742; 9.9678; 11.7421; 9.8335; 12.0257; 9.9487 | — |
| SECONDARY Volume of T1 Hypointense Lesions |
3.9869; 3.6320; 4.3062; 3.6529; 4.3171; 3.7494 | — |
| SECONDARY Volume of Gd-Enhancing Lesions |
0.0911; 0.0348; 0.1172; 0.0477; 0.1346; 0.0357 | — |
| SECONDARY Percentage Change of Whole Brain Volume |
-0.522; -0.453; -0.835; -0.788 | — |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) |
2.43; 2.35; 0.02; 0.00; 0.02; 0.00 | — |
| SECONDARY Time to Sustained Disability Progression |
0.023; 0.007; 0.046; 0.023; 0.079; 0.045 | 0.0060 sig |
| SECONDARY Change From Baseline in Symbol Digit Modalities Test (SDMT) |
52.134; 52.744; -0.313; -1.106; -0.365; -0.864 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score |
20.494; 20.218; -0.152; 0.552; 0.462; 0.545 | — |
| SECONDARY Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) |
47.803; 48.591; 0.396; -0.734; 0.409; -0.690 | — |
| SECONDARY Change From Baseline in SF-12 Physical Component Score (PCS) |
45.154; 44.902; 0.138; 0.337; -0.351; 0.214 | — |
| SECONDARY Change From Baseline in Euro Quality of Life (EQ-5D) Index Score |
0.76; 0.76; 0.00; 0.00; -0.01; 0.00 | — |
| SECONDARY Change From Baseline in EQ-5D Visual Analogue Scale (VAS) |
77.07; 77.33; -0.22; -0.98; -0.81; -0.93 | — |
| SECONDARY Number of Relapses Requiring IV Steroid Use |
217; 181 | — |
| SECONDARY Number of MS-Related Hospitalizations |
113; 81 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? |
6.8; 7.0; 7.2; 7.1; 7.5; 7.3 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? |
8.2; 8.0; 8.3; 8.2; 8.3; 8.0 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? |
8.4; 8.4; 8.6; 8.4; 8.6; 8.5 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? |
7.9; 8.1; 8.2; 8.3; 8.2; 8.6 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? |
8.4; 8.3; 8.5; 8.3; 8.7; 8.6 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? |
8.5; 8.6; 8.1; 8.3; 8.5; 8.8 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS. |
7.3; 7.8; 7.8; 7.8; 8.0; 8.3 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. |
7.4; 7.7; 7.8; 7.7; 7.9; 8.3 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation. |
8.2; 8.2; 8.3; 8.2; 8.6; 8.5 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. |
8.1; 8.2; 8.3; 8.2; 8.5; 8.4 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. |
7.5; 7.7; 7.9; 7.9; 8.1; 8.4 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. |
8.4; 8.5; 8.7; 8.5; 8.8; 8.7 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? |
474; 487; 8; 4; 0; 2 | — |
| SECONDARY Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections |
0; 1; 0; 0; 2; 1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01332019) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.