Trial · NCT00906399
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
NCT00906399, Phase 3, Completed, Biogen; results first posted 2014-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis. Trials, record NCT00906399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00906399
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
- NCT number
- NCT00906399
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,516 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- BIIB017 (peginterferon beta-1a), Placebo
- First posted
- 2009-05-21
- Last updated
- 2014-09-19
- Other registries' IDs
- eudract:2008-006333-27
- Results first posted
- 2014-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) at 1 Year | 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 | Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year | 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. |
| Secondary | Proportion of Participants Relapsed at 1 Year | 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. |
| Secondary | Estimated Proportion of Participants With Sustained Disability Progression at 1 Year | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate (ARR) at 1 Year | 1 Year | Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). | relapses per person-years | NUMBER |
| SECONDARY | Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year | 1 Year | ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit. | lesions | MEAN |
| SECONDARY | Proportion of Participants Relapsed at 1 Year | Year 1 | ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal. | proportion of participants | NUMBER |
| SECONDARY | Estimated Proportion of Participants With Sustained Disability Progression at 1 Year | 1 Year | ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate (ARR) at 1 Year | Year 1: Placebo | 0.397 | 95% Confidence Interval 0.328 to 0.481 | relapses per person-years | |
| Annualized Relapse Rate (ARR) at 1 Year | Year 1: Peginterferon Beta-1a Q4W | 0.288 | 95% Confidence Interval 0.234 to 0.355 | relapses per person-years | |
| Annualized Relapse Rate (ARR) at 1 Year | Year 1: Peginterferon Beta-1a Q2W | 0.256 | 95% Confidence Interval 0.206 to 0.318 | relapses per person-years | |
| Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year | Year 1: Placebo | 10.9 | 95% Confidence Interval 19.51 | lesions | |
| Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year | Year 1: Peginterferon Beta-1a Q4W | 7.9 | 95% Confidence Interval 15.84 | lesions | |
| Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year | Year 1: Peginterferon Beta-1a Q2W | 3.6 | 95% Confidence Interval 8.55 | lesions | |
| Proportion of Participants Relapsed at 1 Year | Year 1: Placebo | 0.291 | proportion of participants | ||
| Proportion of Participants Relapsed at 1 Year | Year 1: Peginterferon Beta-1a Q4W | 0.222 | proportion of participants | ||
| Proportion of Participants Relapsed at 1 Year | Year 1: Peginterferon Beta-1a Q2W | 0.187 | proportion of participants | ||
| Estimated Proportion of Participants With Sustained Disability Progression at 1 Year | Year 1: Placebo | 0.105 | proportion of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 | STARTED | Year 1: Placebo | 500 | |
| Year 1 | STARTED | Year 1: Peginterferon Beta-1a Q4W | 501 | |
| Year 1 | STARTED | Year 1: Peginterferon Beta-1a Q2W | 515 | |
| Year 1 | STARTED | Year 2: Placebo Followed by Peginterferon Beta-1a Q4W | 0 | |
| Year 1 | STARTED | Year 2: Placebo Followed by Peginterferon Beta-1a Q2W | 0 | |
| Year 1 | STARTED | Year 2: Peginterferon Beta-1a Q4W | 0 | |
| Year 1 | STARTED | Year 2: Peginterferon Beta-1a Q2W | 0 | |
| Year 1 | Completed Year 1 Study Treatment | Year 1: Placebo | 456 | |
| Year 1 | Completed Year 1 Study Treatment | Year 1: Peginterferon Beta-1a Q4W | 438 | |
| Year 1 | Completed Year 1 Study Treatment | Year 1: Peginterferon Beta-1a Q2W | 438 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events1,246
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Year 1: Placebo | 77 | 499 | |
| other | Nasopharyngitis | Infections and infestations | Year 1: Peginterferon Beta-1a Q4W | 69 | 500 | |
| other | Nasopharyngitis | Infections and infestations | Year 1: Peginterferon Beta-1a Q2W | 54 | 513 | |
| other | Nasopharyngitis | Infections and infestations | Year 2: Placebo Followed by Peginterferon Beta-1a Q4W | 22 | 227 | |
| other | Nasopharyngitis | Infections and infestations | Year 2: Placebo Followed by Peginterferon Beta-1a Q2W | 17 | 228 | |
| other | Nasopharyngitis | Infections and infestations | Year 2: Peginterferon Beta-1a Q4W | 45 | 439 | |
| other | Nasopharyngitis | Infections and infestations | Year 2: Peginterferon Beta-1a Q2W | 47 | 438 | |
| other | Urinary Tract Infection | Infections and infestations | Year 1: Placebo | 20 | 499 | |
| other | Urinary Tract Infection | Infections and infestations | Year 1: Peginterferon Beta-1a Q4W | 28 | 500 | |
| other | Urinary Tract Infection | Infections and infestations | Year 1: Peginterferon Beta-1a Q2W | 28 | 513 |
1 to 10 of 1,246Source ClinicalTrials.gov
See all 1,246 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Year 1: Placebo | ||
| Total, all-cause mortality | Year 1: Peginterferon Beta-1a Q4W | ||
| Total, all-cause mortality | Year 1: Peginterferon Beta-1a Q2W | ||
| Total, all-cause mortality | Year 2: Placebo Followed by Peginterferon Beta-1a Q4W | ||
| Total, all-cause mortality | Year 2: Placebo Followed by Peginterferon Beta-1a Q2W | ||
| Total, all-cause mortality | Year 2: Peginterferon Beta-1a Q4W | ||
| Total, all-cause mortality | Year 2: Peginterferon Beta-1a Q2W | ||
| Total, other adverse events | Year 1: Placebo | 378 | 499 |
| Total, other adverse events | Year 1: Peginterferon Beta-1a Q4W | 466 | 500 |
| Total, other adverse events | Year 1: Peginterferon Beta-1a Q2W | 472 | 513 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00906399
GET https://conductscience.org/api/trials/v1/NCT00906399/flow?page=2