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Comparison · NCT02605642-sae

Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive vs Participants Who Switched From Remicade to CT-P13: 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. Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive vs Participants Who Switched From Remicade to CT-P13: serious adverse events. Trial comparisons, record NCT02605642-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02605642-sae

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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 10.0860.05570.13wilson
Risk in group 20.09350.05160.164wilson
Risk difference, group 1 minus group 2-0.00749-0.08380.0536newcombe hybrid score
Risk ratio, group 1 over group 20.920.4431.91log
Odds ratio, group 1 over group 20.9120.4092.04log
Number needed to treat, for one fewer participant with a serious adverse event on Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive than on Participants Who Switched From Remicade to CT-P13
134from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive
BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.
19221EG000
Group 2Participants Who Switched From Remicade to CT-P13
Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
10107EG001

Harm

What it counts
Total, serious adverse events
Time frame
During the observation period of 2 years

Source ClinicalTrials.gov

Trial

Title
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
NCT number
NCT02605642
Phases
Conditions
Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Interventions
CT-P13
Lead sponsor
Pfizer
Results first posted
2020-01-13

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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