Comparison · NCT01114880-ecdd78dc
Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS5/6 Response Criteria
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. Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS5/6 Response Criteria. Trial comparisons, record NCT01114880-ecdd78dc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01114880-ecdd78dc
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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 | 0.559 | 0.494 | 0.622 | wilson | |
| Risk in group 2 | 0.122 | 0.0739 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0.437 | 0.34 | 0.516 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.59 | 2.77 | 7.6 | log | |
| Odds ratio, group 1 over group 2 | 9.14 | 4.93 | 16.9 | log | |
| Number needed to treat, for one more participant with the outcome on Adalimumab/Adalimumab than on Placebo/Adalimumab | 2.29 | 1.94 | 2.94 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Adalimumab/Adalimumab | Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22 | 128 | 229 | OG000 |
| Group 2 | Placebo/Adalimumab | Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22 | 14 | 115 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Meeting the ASAS5/6 Response Criteria
- Description
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index \[BASMI\]); and acute phase reactant (high-sensitivity C-reactive protein).
- Time frame
- Week 12
- Population
- ITT analysis set, missing data imputed by NRI
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
- NCT number
- NCT01114880
- Phases
- PHASE3
- Conditions
- Ankylosing Spondylitis
- Interventions
- adalimumab, placebo
- Lead sponsor
- Abbott
- Results first posted
- 2011-11-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01114880?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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