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Comparison · NCT03120949-deaths

Treatment Arm 1: OKZ 64 mg q4w + MTX vs Treatment Arm 2: OKZ 64 mg q2w + MTX: deaths from any cause

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. Treatment Arm 1: OKZ 64 mg q4w + MTX vs Treatment Arm 2: OKZ 64 mg q2w + MTX: deaths from any cause. Trial comparisons, record NCT03120949-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03120949-deaths

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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 10.01250.00730.0212wilson
Risk in group 20.01230.007170.0209wilson
Risk difference, group 1 minus group 20.000211-0.009820.0103newcombe hybrid score
Risk ratio, group 1 over group 21.020.4742.18log
Odds ratio, group 1 over group 21.020.4692.21log
Number needed to harm, for one more death from any cause on Treatment Arm 1: OKZ 64 mg q4w + MTX than on Treatment Arm 2: OKZ 64 mg q2w + MTX4,730from 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 1Treatment Arm 1: OKZ 64 mg q4w + MTX
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
131,043EG000
Group 2Treatment Arm 2: OKZ 64 mg q2w + MTX
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
131,061EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
NCT number
NCT03120949
Phases
PHASE3
Conditions
Rheumatoid Arthritis
Interventions
Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w, Concomitant treatment
Lead sponsor
R-Pharm International, LLC
Results first posted
2022-06-07

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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