Comparison · NCT01543503-42e10a44
Tocilizumab vs TNF Inhibitor: Loss of Efficacy or Development of Intolerance to Biologic Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Tocilizumab vs TNF Inhibitor: Loss of Efficacy or Development of Intolerance to Biologic Therapy. Trial comparisons, record NCT01543503-42e10a44. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01543503-42e10a44
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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 | 0.0355 | 0.0216 | 0.0577 | wilson | |
| Risk in group 2 | 0.134 | 0.112 | 0.159 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0982 | -0.127 | -0.067 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.265 | 0.157 | 0.45 | log | |
| Odds ratio, group 1 over group 2 | 0.238 | 0.137 | 0.415 | log | |
| Number needed to treat, for one fewer participant with the outcome on Tocilizumab than on TNF Inhibitor | 10.2 | 7.86 | 14.9 | from the risk difference interval |
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 | Tocilizumab | Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks. | 15 | 423 | OG000 |
| Group 2 | TNF Inhibitor | Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks. | 106 | 793 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Loss of Efficacy or Development of Intolerance to Biologic Therapy
- Description
Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.
- Time frame
- Up to Week 52
- Population
- The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.
Source ClinicalTrials.gov
Trial
- Title
- An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
- NCT number
- NCT01543503
- Phases
- Conditions
- Rheumatoid Arthritis
- Interventions
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01543503?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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