Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis (ADVANCE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00906399 |
|
Recruitment Status :
Completed
First Posted : May 21, 2009
Results First Posted : September 19, 2014
Last Update Posted : September 19, 2014
|
Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing Multiple Sclerosis | Drug: BIIB017 (peginterferon beta-1a) Drug: Placebo | Phase 3 |
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1516 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis |
| Study Start Date : | June 2009 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | October 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
|
Drug: BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Other Names:
Drug: Placebo Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection. |
|
Experimental: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
|
Drug: BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Other Names:
|
|
Experimental: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
|
Drug: BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Other Names:
Drug: Placebo Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection. |
Primary Outcome Measures :
- Annualized Relapse Rate (ARR) at 1 Year [ Time Frame: 1 Year ]A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
Secondary Outcome Measures :
- Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year [ Time Frame: 1 Year ]Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.
- Proportion of Participants Relapsed at 1 Year [ Time Frame: Year 1 ]A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.
- Estimated Proportion of Participants With Sustained Disability Progression at 1 Year [ Time Frame: 1 Year ]Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
- Must have an EDSS score between 0.0 and 5.0.
- Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
Key Exclusion Criteria:
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
- Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906399
Locations
Show 178 study locations
Sponsors and Collaborators
Biogen
Investigators
| Study Director: | Medical Director | Biogen |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT00906399 |
| Other Study ID Numbers: |
105MS301 2008-006333-27 ( EudraCT Number ) |
| First Posted: | May 21, 2009 Key Record Dates |
| Results First Posted: | September 19, 2014 |
| Last Update Posted: | September 19, 2014 |
| Last Verified: | September 2014 |
Keywords provided by Biogen:
|
interferon injectable MS SC PEGylated |
Interferon beta-1a relapsing PEG multiple sclerosis subcutaneous |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Interferons Interferon-beta Interferon beta-1a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |