NCT00422383 · OUTCOME
Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers
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
ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.
Analysis population: SAP, 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 | 113 |
|---|
| Rituximab Escalated Dose + Methotrexate | 107 |
|---|
| Rituximab High Dose + Methotrexate | 86 |
|---|
| Rituximab/Placebo + Methotrexate | 4 |
|---|
| Rituximab Decreased Dose + Methotrexate | 24 |
|---|
Reported measurements
Wk 24, Negative to Borderline (n=113,107,80,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 7.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 1.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 7.5 | 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 | 4.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 24, Borderline to Negative (n=113,107,80,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 14.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 16.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 11.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 25.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 24, Borderline to Positive (n=113,107,80,4,24)
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 | 1.3 | 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, Positive to Borderline (n=113,107,80,4,24)
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 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 6.3 | 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, Positive to Negative (n=113,107,80,4,24)
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 | 1.3 | 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, Unchanged (n=113,107,80,4,24)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 77.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 79.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 72.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 75.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 95.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, Negative to Borderline (n=112,102,86,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 2.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 2.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 2.3 | 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, Borderline to Negative (n=112,102,86,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 23.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 24.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 16.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 9.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, Borderline to Positive (n=112,102,86,4,22)
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 | 1.0 | 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 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Wk 48, Positive to Borderline (n=112,102,86,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 5.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 3.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 7.0 | 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, Positive to Negative (n=112,102,86,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 2.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 3.5 | 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, Unchanged (n=112,102,86,4,22)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 64.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 66.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 70.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab/Placebo + Methotrexate | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab Decreased Dose + Methotrexate | 86.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7.1
- group Id
- OG001
- value
- 1.9
- group Id
- OG002
- value
- 7.5
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 4.2
- title
- Wk 24, Negative to Borderline (n=113,107,80,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 14.2
- group Id
- OG001
- value
- 16.8
- group Id
- OG002
- value
- 11.3
- group Id
- OG003
- value
- 25.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, Borderline to Negative (n=113,107,80,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 1.3
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, Borderline to Positive (n=113,107,80,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 0.9
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 6.3
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, Positive to Borderline (n=113,107,80,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.9
- group Id
- OG002
- value
- 1.3
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 24, Positive to Negative (n=113,107,80,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 77.9
- group Id
- OG001
- value
- 79.4
- group Id
- OG002
- value
- 72.5
- group Id
- OG003
- value
- 75.0
- group Id
- OG004
- value
- 95.8
- title
- Wk 24, Unchanged (n=113,107,80,4,24)
- categories
- measurements
- group Id
- OG000
- value
- 2.7
- group Id
- OG001
- value
- 2.0
- group Id
- OG002
- value
- 2.3
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 48, Negative to Borderline (n=112,102,86,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 23.2
- group Id
- OG001
- value
- 24.5
- group Id
- OG002
- value
- 16.3
- group Id
- OG003
- value
- 50.0
- group Id
- OG004
- value
- 9.1
- title
- Wk 48, Borderline to Negative (n=112,102,86,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 1.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 48, Borderline to Positive (n=112,102,86,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 5.4
- group Id
- OG001
- value
- 3.9
- group Id
- OG002
- value
- 7.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 4.5
- title
- Wk 48, Positive to Borderline (n=112,102,86,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 4.5
- group Id
- OG001
- value
- 2.0
- group Id
- OG002
- value
- 3.5
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- title
- Wk 48, Positive to Negative (n=112,102,86,4,22)
- categories
- measurements
- group Id
- OG000
- value
- 64.3
- group Id
- OG001
- value
- 66.7
- group Id
- OG002
- value
- 70.9
- group Id
- OG003
- value
- 50.0
- group Id
- OG004
- value
- 86.4
- title
- Wk 48, Unchanged (n=112,102,86,4,22)
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 86
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 24
- units
- Participants
- description
- ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.
- 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
- SAP, 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 a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice
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