TriangleNCT00282308 · OUTCOME
Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- IU/mL
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B
What was measured
Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.
Analysis population: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
Groups in this outcome
Rituximab + Methotrexate (Group A)
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
Methotrexate (Group B)
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
| Group | Source count |
|---|---|
| Rituximab + Methotrexate (Group A) | 64 |
| Methotrexate (Group B) | 27 |
Reported measurements
Pre-vaccination
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab + Methotrexate (Group A) | 345.7 | Not reported | 312.25 | 382.76 | Not reported |
| Methotrexate (Group B) | 388.0 | Not reported | NA | NA | The confidence interval could not be calculated as only 1 patient had an anti-body response above the lower limit of quantitation. |
4 weeks post-vaccination
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab + Methotrexate (Group A) | 539.5 | Not reported | 461.54 | 630.61 | Not reported |
| Methotrexate (Group B) | 1585.5 | Not reported | 1065.15 | 2360.17 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 312.25
- upper Limit
- 382.76
- value
- 345.7
- comment
- The confidence interval could not be calculated as only 1 patient had an anti-body response above the lower limit of quantitation.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 388.0
- title
- Pre-vaccination
- categories
- measurements
- group Id
- OG000
- lower Limit
- 461.54
- upper Limit
- 630.61
- value
- 539.5
- group Id
- OG001
- lower Limit
- 1065.15
- upper Limit
- 2360.17
- value
- 1585.5
- title
- 4 weeks post-vaccination
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
- id
- OG000
- title
- Rituximab + Methotrexate (Group A)
- description
- Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
- id
- OG001
- title
- Methotrexate (Group B)
- param Type
- GEOMETRIC_MEAN
- population Description
- Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
- reporting Status
- POSTED
- time Frame
- Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B
- title
- Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin
- type
- SECONDARY
- unit Of Measure
- IU/mL
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Preserved source evidence · Not medical advice