| Primary | Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)] | For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined. RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of participants | | Baseline (Week 0) to Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Yes | | | | No | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %. A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed. | ANCOVA | Difference in proportions from ANCOVA with tool as factor & Baseline DAS28(ESR), gender, age, prior anti-TNF use & disease duration as covariates. | | Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools. | Difference in proportion | -0.119 | | | 2-Sided | 95 | -0.184 | -0.053 | | | |
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| Primary | Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52 | For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of participants | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 |
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| Secondary | Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52 | For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of participants | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia |
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| Secondary | Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52 | For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined. | The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages. The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis. | Posted | | Number | | percentage of participants | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52 | For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of participants | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia |
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| Secondary | Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12 | The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 0) to Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52 | The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 0) to Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12 | RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 0) to Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52 | RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 0) to Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12 | DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52 | DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12 | DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52 | DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12 | RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52 | RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12 | RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52 | RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Number of work days missed in last month | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Work days with reduced work productivity | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Days with no household work | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Days with reduced household work | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Activity days missed | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Days with hired outside help | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 | The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Number of work days missed in last month | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Work days with reduced work productivity | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Days with no household work | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Days with reduced household work | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Activity days missed | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | Days with hired outside help | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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| Secondary | Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. | The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | RAPID3 to Assess Response to Cimzia | RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points | | OG001 | CDAI to Assess Response to Cimzia | CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI) |
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