TriangleNCT00299130 · OUTCOME
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
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
- Baseline and Week 24
What was measured
To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 100 mm VAS); * Patient's assessment of pain (assessed using a 100 mm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR). Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders.
Analysis population: Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.
Groups in this outcome
Placebo + MTX
Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 0.5 g + MTX
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 1.0 g + MTX
Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
| Group | Source count |
|---|---|
| Placebo + MTX | 172 |
| Rituximab 2 x 0.5 g + MTX | 167 |
| Rituximab 2 x 1.0 g + MTX | 170 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 23.3 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 54.5 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 50.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23.3
- group Id
- OG001
- value
- 54.5
- group Id
- OG002
- value
- 50.6
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 100 mm VAS); * Patient's assessment of pain (assessed using a 100 mm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR). Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders.
- groups
- description
- Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG000
- title
- Placebo + MTX
- description
- Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG001
- title
- Rituximab 2 x 0.5 g + MTX
- description
- Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG002
- title
- Rituximab 2 x 1.0 g + MTX
- param Type
- NUMBER
- population Description
- Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 24
- title
- Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice