Comparison · NCT03120949-9e601661
Treatment Arm 1: OKZ 64 mg q4w + MTX vs Treatment Arm 2: OKZ 64 mg q2w + MTX: Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
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: Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment. Trial comparisons, record NCT03120949-9e601661. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03120949-9e601661
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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 | 0.0834 | 0.0681 | 0.102 | wilson | |
| Risk in group 2 | 0.0848 | 0.0695 | 0.103 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00141 | -0.0253 | 0.0225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.983 | 0.742 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 0.982 | 0.722 | 1.34 | log | |
| Number needed to treat, for one fewer participant with the outcome on Treatment Arm 1: OKZ 64 mg q4w + MTX than on Treatment Arm 2: OKZ 64 mg q2w + MTX | 708 | 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 | Treatment 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. | 87 | 1,043 | OG000 |
| Group 2 | Treatment 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. | 90 | 1,061 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
- Description
- Time frame
- up to Week 126
- Population
- Safety Population (3 Subjects discontinued treatment due to an AE but they did not have an AE that led to treatment discontinuation.)
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03120949?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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