Comparison · NCT01309997-5bd92d2b
Arm I (Enzyme Inhibitor) vs Arm II (Monoclonal Antibody): Significant Clinical Response
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. Arm I (Enzyme Inhibitor) vs Arm II (Monoclonal Antibody): Significant Clinical Response. Trial comparisons, record NCT01309997-5bd92d2b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01309997-5bd92d2b
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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 | 0.3 | 0.167 | 0.479 | wilson | |
| Risk in group 2 | 0.323 | 0.186 | 0.499 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0226 | -0.243 | 0.203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.93 | 0.44 | 1.96 | log | |
| Odds ratio, group 1 over group 2 | 0.9 | 0.304 | 2.66 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm I (Enzyme Inhibitor) than on Arm II (Monoclonal Antibody) | 44.3 | 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 | Arm I (Enzyme Inhibitor) | Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. | 9 | 30 | OG000 |
| Group 2 | Arm II (Monoclonal Antibody) | Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. | 10 | 31 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Significant Clinical Response
- Description
Assessed by decline in an affected area's skin score as measured with the Vienna Skin Scale (from 4 \[worst\] to 2, 3 to 1, or 2 to 0 \[best\]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.
- Time frame
- 6 months
- Population
- Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.
Source ClinicalTrials.gov
Trial
- Title
- Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
- NCT number
- NCT01309997
- Phases
- PHASE2
- Conditions
- Graft Versus Host Disease, Systemic Scleroderma
- Interventions
- imatinib mesylate, rituximab
- Lead sponsor
- Lee, Stephanie
- Results first posted
- 2016-06-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01309997?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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