Comparison · NCT01281969-0bbb7ac6
IVIG vs Placebo: The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration.
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. IVIG vs Placebo: The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration. Trial comparisons, record NCT01281969-0bbb7ac6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01281969-0bbb7ac6
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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 | 0.471 | 0.262 | 0.69 | wilson | |
| Risk in group 2 | 0.278 | 0.125 | 0.509 | wilson | |
| Risk difference, group 1 minus group 2 | 0.193 | -0.119 | 0.46 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.69 | 0.689 | 4.16 | log | |
| Odds ratio, group 1 over group 2 | 2.31 | 0.568 | 9.41 | log | |
| Number needed to treat, for one more participant with the outcome on IVIG than on Placebo | 5.19 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | IVIG | Gamunex Intravenous Immunoglobulin: 2.0 gm/kg total, IV (in the vein), over 2 days | 8 | 17 | OG000 |
| Group 2 | Placebo | Placebo: Normal saline, IV (in the vein), over 2 days | 5 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration.
- Description
Non-zero values of antinuclear antibodies are considered positive and reflective of an ongoing immune response in the individual. First, the number of participants who were classified at baseline as having positive antinuclear antibodies was calculated (see outcome measure data table, which states the number (AKA count) of participants who had positive antinuclear antibodies at baseline). We hypothesized that improvement in the ongoing immune response, and therefore a reduction in antinuclear antibody titers, would mediate the effect of IVIG on OCD symptom improvement. However, because very few participants were classified as positive at baseline, it was not appropriate to pursue the original question of whether a decline in antinuclear antibodies (i.e., from positive to negative) was related to symptom improvement.
- Time frame
- Baseline
- Population
Source ClinicalTrials.gov
Trial
- Title
- Intravenous Immunoglobulin for PANDAS
- NCT number
- NCT01281969
- Phases
- PHASE3
- Conditions
- Obsessive-Compulsive Disorder, Children, Anxiety Disorder, Autoimmune Disease, PANDAS
- Interventions
- Gamunex Intravenous Immunoglobulin, Placebo
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Results first posted
- 2020-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01281969?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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