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Comparison · NCT02270957-79ea4969

Abatacept vs Placebo: 4 Point Improvement in the SLE Disease Activity Index (SLEDAI)

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: 4 Point Improvement in the SLE Disease Activity Index (SLEDAI). Trial comparisons, record NCT02270957-79ea4969. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02270957-79ea4969

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.290.1610.466wilson
Risk in group 20.2290.1210.39wilson
Risk difference, group 1 minus group 20.0618-0.1450.268newcombe hybrid score
Risk ratio, group 1 over group 21.270.5592.89log
Odds ratio, group 1 over group 21.380.4574.17log
Number needed to treat, for one more participant with the outcome on Abatacept than on Placebo16.2from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Abatacept
Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.~Abatacept
931OG000
Group 2Placebo
Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.~Placebo
835OG001

Outcome

Type
POST_HOC
Title
4 Point Improvement in the SLE Disease Activity Index (SLEDAI)
Description
The SLEDAI is a discontinuous scoring system that weights disease activity not by severity of individual symptoms but by the weighting of organs. This makes it less robust for comparing one group of patients to another, but it is quite useful to gave numbers of patients with improvement, since to lower the score a rigorous improvement must be documented
Time frame
Comparison of Baseline to 6 months
Population
Full Analysis Set of all randomized patients

Source ClinicalTrials.gov

Trial

Title
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
NCT number
NCT02270957
Phases
PHASE2
Conditions
Systemic Lupus Erythematosus
Interventions
Abatacept, Placebo
Lead sponsor
Oklahoma Medical Research Foundation
Results first posted
2020-11-25

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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