NCT00422383 · OUTCOME
Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- BL, Weeks 24 and 48
What was measured
The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.
Analysis population: ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.
Groups in this outcome
Rituximab Low Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab Escalated Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab High Dose + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab/Placebo + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
Rituximab Decreased Dose + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab Low Dose + Methotrexate | 131 |
|---|
| Rituximab Escalated Dose + Methotrexate | 113 |
|---|
| Rituximab High Dose + Methotrexate | 93 |
|---|
| Rituximab/Placebo + Methotrexate | 6 |
|---|
| Rituximab Decreased Dose + Methotrexate | 25 |
|---|
Reported measurements
BL, total Ig <LLN (n=131,113,93,6,25)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 1.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
BL, total IgA <LLN (n=131,113,93,6,25)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 2.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
BL, total IgG <LLN (n=131,113,93,6,25)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 2.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 2.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
BL, total IgM <LLN (n=131,113,93,6,25)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 1.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 4.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 24, total Ig <LLN (n=117,109,83,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 24, total IgA <LLN (n=117,109,83,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 1.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 24, total IgG <LLN (n=117,109,83,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 24, total IgM <LLN (n=117,109,83,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 7.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 7.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 6.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 16.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, total Ig <LLN (n=117,105,89,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 0.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, total IgA <LLN (n=117,105,89,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 1.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 1.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 2.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, total IgG <LLN (n=117,105,89,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 1.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, total IgM <LLN (n=117,105,89,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 13.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 13.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 10.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 18.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 1.1
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- BL, total Ig <LLN (n=131,113,93,6,25)
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 2.2
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- BL, total IgA <LLN (n=131,113,93,6,25)
- categories
- measurements
- group Id
- OG000
- value
- 2.3
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 2.2
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- BL, total IgG <LLN (n=131,113,93,6,25)
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 1.1
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 4.0
- title
- BL, total IgM <LLN (n=131,113,93,6,25)
- categories
- measurements
- group Id
- OG000
- value
- 0.9
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, total Ig <LLN (n=117,109,83,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 1.2
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, total IgA <LLN (n=117,109,83,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 0.9
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, total IgG <LLN (n=117,109,83,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 7.7
- group Id
- OG001
- value
- 7.3
- group Id
- OG002
- value
- 6.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 16.7
- title
- Wk 24, total IgM <LLN (n=117,109,83,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 0.9
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 4.5
- title
- Wk 48, total Ig <LLN (n=117,105,89,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 1.7
- group Id
- OG001
- value
- 1.0
- group Id
- OG002
- value
- 2.2
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 48, total IgA <LLN (n=117,105,89,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 1.7
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 4.5
- title
- Wk 48, total IgG <LLN (n=117,105,89,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 13.7
- group Id
- OG001
- value
- 13.3
- group Id
- OG002
- value
- 10.1
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 18.2
- title
- Wk 48, total IgM <LLN (n=117,105,89,4,22)
- denoms
- counts
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 113
- group Id
- OG002
- value
- 93
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 25
- units
- Participants
- description
- The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.
- groups
- description
- Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG000
- title
- Rituximab Low Dose + Methotrexate
- description
- Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG001
- title
- Rituximab Escalated Dose + Methotrexate
- description
- Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG002
- title
- Rituximab High Dose + Methotrexate
- description
- Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
- id
- OG003
- title
- Rituximab/Placebo + Methotrexate
- description
- Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
- id
- OG004
- title
- Rituximab Decreased Dose + Methotrexate
- param Type
- NUMBER
- population Description
- ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- BL, Weeks 24 and 48
- title
- Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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