Comparison · NCT00774852-sae
Abatacept vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Abatacept vs Placebo: serious adverse events. Trial comparisons, record NCT00774852-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00774852-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 | 0.406 | 0.298 | 0.524 | wilson | |
| Risk in group 2 | 0.382 | 0.276 | 0.501 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0234 | -0.137 | 0.182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.7 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.556 | 2.19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Abatacept than on Placebo | 42.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Abatacept | Subjects received abatacept IV dosed according to body weight (\<60 kg, 500mg; 60-100 kg, 750 mg; or \>100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).\* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.\* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.\* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). \*Based on principal investigator \[PI\] judgment. | 28 | 69 | EG000 |
| Group 2 | Placebo | Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.\*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.\* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.\* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. \*Based on principal investigator \[PI\] judgment. | 26 | 68 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment through last follow-up visit (up to 104 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
- NCT number
- NCT00774852
- Phases
- PHASE2
- Conditions
- Lupus Nephritis, Lupus Erythematosus, Systemic
- Interventions
- abatacept, cyclophosphamide, azathioprine, prednisone, abatacept placebo, azathioprine placebo
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2014-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00774852?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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