Comparison · NCT03649061-sae
Standard COBRA-Slim Induction vs COBRA-Slim Bio-induction: serious adverse events
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. Standard COBRA-Slim Induction vs COBRA-Slim Bio-induction: serious adverse events. Trial comparisons, record NCT03649061-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03649061-sae
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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 | 0.0727 | 0.0286 | 0.173 | wilson | |
| Risk in group 2 | 0.0909 | 0.0395 | 0.196 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0182 | -0.132 | 0.0942 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.8 | 0.227 | 2.82 | log | |
| Odds ratio, group 1 over group 2 | 0.784 | 0.199 | 3.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard COBRA-Slim Induction than on COBRA-Slim Bio-induction | 55 | 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 | Standard COBRA-Slim Induction | Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)~Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme | 4 | 55 | EG000 |
| Group 2 | COBRA-Slim Bio-induction | Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)~Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme | 5 | 55 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
Source ClinicalTrials.gov
Trial
- Title
- COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
- NCT number
- NCT03649061
- Phases
- PHASE4
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Etanercept 50 MG/ML, Leflunomide 10 milligram (MG)
- Lead sponsor
- P. Verschueren
- Results first posted
- 2025-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03649061?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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