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| ID | Type | Description | Link |
|---|---|---|---|
| B1801019 |
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| Name | Class |
|---|---|
| Lincoln Medical and Mental Health Center | OTHER |
| Umanis | INDUSTRY |
| SODIA | UNKNOWN |
| depolabo |
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The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite score based on patient reported outcomes, and includes such criteria as pain, functional disability, fatigue, sleep disturbances, coping, overall assessment of physical well being and overall assessment of psychological well being. The objective of this study is to evaluate the practical modalities and performance of the EULAR- RAID score in patients with rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept 50 mg once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score | EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial). | Screening, baseline |
| Simplicity: Time for Completion of the EULAR-RAID Questionnaire | EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). | Baseline up to Week 12 |
| Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28) | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity. | Baseline, Week 4 |
| Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12 | EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Amiens | 80054 | France | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33547229 | Derived | Duarte C, Santos EJF, Ferreira RJO, Kvien TK, Dougados M, de Wit M, da Silva JAP, Gossec L. Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients. RMD Open. 2021 Feb;7(1):e001539. doi: 10.1136/rmdopen-2020-001539. | |
| 22647431 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Study duration includes a screening period of up to 6 weeks, a 12 week open-label treatment period, and a 4 week follow-up period (telephone contact for the assessment of adverse events).
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept (ETN) | Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept (ETN) | Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score | EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial). | All injected subjects population: received at least 1 dose of study treatment (same as Safety population). | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient | Screening, baseline |
|
Time the Informed Consent Form was signed up to Week 16 Follow-up visit
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept (ETN) | Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Week 12 |
| Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average | Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity. | Baseline, Last observation up to Week 12 |
| Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status | PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85). | Baseline, Week 4 |
| Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12 | PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85). | Week 12 |
| Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average | Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85). | Baseline, Last observation up to Week 12 |
| Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 | Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score. | Baseline, Week 4 |
| Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 | Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score. | Baseline, Week 12 |
| Week 12 |
| Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 | MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement. | Week 4, Week 12 |
| Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs) | MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation. | Week 4, Week 12, and Last observation up to Week 12 |
| Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs) | MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation. | Week 4, Week 12, and Last observation up to Week 12 |
| Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 | PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable. | Week 4, Week 12 |
| Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs) | PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation. | Week 4, Week 12, and Last observation up to Week 12 |
| Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs) | PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation. | Week 4, Week 12, and Last observation up to Week 12 |
| Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2). | Week 12 |
| Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. | Week 12 |
| Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. | Week 12 |
| Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6). | Week 12 |
| Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2 | Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. | Baseline up to Week 12 |
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12 | American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | Week 12 |
| Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 | American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | Week 12 |
| Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12 | American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | Week 12 |
| Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12 | American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | Week 12 |
| Amiens |
| 80090 |
| France |
| Pfizer Investigational Site | Belfort | 90000 | France |
| Pfizer Investigational Site | Berck | 62608 | France |
| Pfizer Investigational Site | Bonneville | 74136 | France |
| Pfizer Investigational Site | Cahors | 49000 | France |
| Pfizer Investigational Site | Corbeil-Essonnes | 91100 | France |
| Pfizer Investigational Site | Créteil | 94010 | France |
| Pfizer Investigational Site | Dijon | 21076 | France |
| Pfizer Investigational Site | Lomme | 59160 | France |
| Pfizer Investigational Site | Montpellier | 34000 | France |
| Pfizer Investigational Site | Mulhouse | 68100 | France |
| Pfizer Investigational Site | Paris | 75674 | France |
| Pfizer Investigational Site | Rodez | 12027 | France |
| Pfizer Investigational Site | Saint-Priest-en-Jarez | 42270 | France |
| Pfizer Investigational Site | Valenciennes | 59322 | France |
| Pfizer Investigational Site | Monaco | 98000 | Monaco |
| Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012 May 30;14(3):R129. doi: 10.1186/ar3859. |
| 22325048 | Derived | Dougados M, Ripert M, Hilliquin P, Brocq O, Brault Y, Logeart I. Onset of action of etanercept in rheumatoid arthritis based on patient-reported outcomes. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):266-8. Epub 2012 Apr 13. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Simplicity: Time for Completion of the EULAR-RAID Questionnaire | EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). | All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping) | Posted | Mean | Standard Deviation | minutes | Baseline up to Week 12 |
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| Primary | Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28) | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity. | All injected subjects population | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline, Week 4 |
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| Primary | Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity. | All injected subjects population | Posted | Number | 95% Confidence Interval | correlation coefficient | Week 12 |
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| Primary | Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average | Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity. | All injected subjects population; score profile from baseline to last observation post-baseline. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline, Last observation up to Week 12 |
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| Primary | Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status | PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85). | All injected subjects population | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline, Week 4 |
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| Primary | Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12 | PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85). | All injected subjects population | Posted | Number | 95% Confidence Interval | correlation coefficient | Week 12 |
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| Primary | Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average | Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85). | All injected subjects population; score profile from baseline to last observation post-baseline. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline, Last observation up to Week 12 |
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| Primary | Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 | Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score. | All injected subjects population | Posted | Number | standardized response mean | Baseline, Week 4 |
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| Primary | Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 | Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score. | All injected subjects population | Posted | Number | standardized response mean | Baseline, Week 12 |
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| Secondary | Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12 | EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]). | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 | MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement. | All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No). | Posted | Number | scores on a scale | Week 4, Week 12 |
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| Secondary | Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs) | MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation. | All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No). | Posted | Number | percentage of participants | Week 4, Week 12, and Last observation up to Week 12 |
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| Secondary | Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs) | MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation. | All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No). | Posted | Number | percentage of participants | Week 4, Week 12, and Last observation up to Week 12 |
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| Secondary | Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 | PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable. | All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable). | Posted | Number | scores on a scale | Week 4, Week 12 |
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| Secondary | Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs) | PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation. | All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable). | Posted | Number | percentage of participants | Week 4, Week 12, and Last observation up to Week 12 |
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| Secondary | Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs) | PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation. | All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable). | Posted | Number | percentage of participants | Week 4, Week 12, and Last observation up to Week 12 |
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| Secondary | Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2). | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12 | DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6). | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2 | Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. | All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration. | Posted | Number | participants | Baseline up to Week 12 |
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| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12 | American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 | American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12 | American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12 | American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR. | All injected subjects population; N=number of participants with evaluable data at observation. | Posted | Number | percentage of participants | Week 12 |
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| 5 |
| 108 |
| 53 |
| 108 |
| Arthritis bacterial | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 12.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 12.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA version 12.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA version 12.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 12.0 | Systematic Assessment |
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Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Title | Measurements |
|---|---|
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| Fatigue NRS value |
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| Sleep NRS value |
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| Physical well-being NRS value |
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| Emotional well-being NRS value |
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| Coping NRS value |
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Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value
| paired t-test |
A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.837 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Sleep NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.035 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.351 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.025 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Coping NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | <0.001 | 2-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Fatigue NRS value |
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| Sleep NRS value |
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| Physical well-being NRS value |
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| Emotional well-being NRS value |
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| Coping NRS value |
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Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value
| paired t-test |
A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. |
| 0.052 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.895 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Sleep NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.153 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.029 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | 0.043 | 2-Sided | No | Superiority or Other |
| Comparison of change from baseline between EULAR-RAID score and Coping NRS value | paired t-test | A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score. | <0.001 | 2-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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