Comparison · NCT00048542-2eb57352
Double-Blind Adalimumab vs Double-Blind Placebo: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase
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. Double-Blind Adalimumab vs Double-Blind Placebo: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase. Trial comparisons, record NCT00048542-2eb57352. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00048542-2eb57352
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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 | 0.433 | 0.274 | 0.608 | wilson | |
| Risk in group 2 | 0.714 | 0.529 | 0.847 | wilson | |
| Risk difference, group 1 minus group 2 | -0.281 | -0.489 | -0.0266 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.607 | 0.379 | 0.972 | log | |
| Odds ratio, group 1 over group 2 | 0.306 | 0.103 | 0.912 | log | |
| Number needed to treat, for one fewer participant with the outcome on Double-Blind Adalimumab than on Double-Blind Placebo | 3.56 | 2.05 | 37.6 | 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| Group 1 | Double-Blind Adalimumab | Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study. | 13 | 30 | OG000 |
| Group 2 | Double-Blind Placebo | Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area \[BSA\], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study. | 20 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase
- Description
The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) \>= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) \>= 30% improvement in not more than 1 of the 6 JRA core set criteria.
- Time frame
- Week 16 to Week 48 (32 weeks)
- Population
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.
Source ClinicalTrials.gov
Trial
- Title
- Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
- NCT number
- NCT00048542
- Phases
- PHASE3
- Conditions
- Arthritis, Juvenile Idiopathic
- Interventions
- Double-Blind Adalimumab/Placebo + MTX, Double-Blind Adalimumab/Placebo, OLE BSA Adalimumab +/- MTX, OLE FD Adalimumab +/- MTX
- Lead sponsor
- Abbott
- Results first posted
- 2010-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00048542?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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