Comparison · NCT01797965-3e93dbb1
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 Relapse 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 Relapse in the 205MS301-303 Combined Study Period. Trial comparisons, record NCT01797965-3e93dbb1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01797965-3e93dbb1
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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 | 0.568 | 0.528 | 0.607 | wilson | |
| Risk in group 2 | 0.431 | 0.392 | 0.47 | wilson | |
| Risk difference, group 1 minus group 2 | 0.137 | 0.0807 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 1.17 | 1.48 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 1.38 | 2.18 | 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) | 7.29 | 5.2 | 12.4 | from the risk difference interval |
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. | 339 | 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. | 261 | 606 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Relapse in the 205MS301-303 Combined Study Period
- Description
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.
- 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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