Comparison · NCT01797965-950d1f6b
IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) vs DAC HYP 150 mg (301) /DAC HYP 150 mg (303): Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) vs DAC HYP 150 mg (301) /DAC HYP 150 mg (303): Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period. Trial comparisons, record NCT01797965-950d1f6b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01797965-950d1f6b
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.241 | 0.209 | 0.277 | wilson | |
| Risk in group 2 | 0.215 | 0.184 | 0.249 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0267 | -0.0207 | 0.074 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.913 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.16 | 0.889 | 1.52 | log | |
| Number needed to treat, for one more participant with the outcome on IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) than on DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 37.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks. | 144 | 597 | OG000 |
| Group 2 | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks. | 130 | 606 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period
- Description
Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability.
- Time frame
- Up to 5.6 years combining 303 with the initial Study 301
- Population
- 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.
Source ClinicalTrials.gov
Trial
- Title
- Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
- NCT number
- NCT01797965
- Phases
- PHASE3
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
- Interventions
- BIIB019 (Daclizumab)
- Lead sponsor
- Biogen
- Results first posted
- 2019-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01797965?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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