A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The overall objective of the study is to assess the effectiveness of switching from immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in patients with moderately to severely active Rheumatoid Arthritis (RA), managed according to standard of care in clinical practice settings.

Detailed Description
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Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone and followed for approximately 12 weeks.

Official Title
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A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: RAYOS (delayed-release prednisone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and in general good health (Investigator discretion) with a recent stable medical history other than related to RA disease activity RA diagnosis is ≥ 6 months according to ACR and/or EULAR classification criteria for diagnosis of active RA Morning stiffness duration of at least 45 minutes at study entry RA disease activity as defined by DAS28 of ≥ 3.2 at study entry Currently receiving conventional immediate-release prednisone ≥ 2.5 milligram (mg) every morning and previously agreed to switch to RAYOS Willing and able to sign an Informed Consent Form (ICF) Exclusion Criteria: Patient is unwilling to participate in the non-interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RAYOS (delayed-release prednisone)|Physicians may prescribe any dosage of RAYOS based on what is appropriate for the treatment of the patient's condition as determined by performing standard of care assessments.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit | Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to Not Severe at All and 100 to Extremely Severe. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit) | The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit) | Patient's Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit) | Physician's Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to Very Well' and 10 to Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow-up visit (up to 18.7 weeks) | 
| Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit) | The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity). DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit) | The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity). DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit) | Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition. As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit) | Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit) | European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined. DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity). | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit) | American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit) | American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit) | American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| ACR-N From Baseline to Final Visit (Final Follow-up Visit) | ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set-Patient's global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician's global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit) | Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up. RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit) | The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - function (FN) was assessed by asking participants to score the performance of multiple activities as without any difficulty (score of 0), with some difficulty (score of 1), with much difficulty (score of 2) or unable to do (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit) | The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as without any difficulty (score of 0), with some difficulty (score of 1.1), with much difficulty (score of 2.2) or unable to do (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit) | Multidimensional Health Assessment Questionnaire (MDHAQ) - pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to No Pain and 10 to Pain as bad as it could be because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit) | For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit) | For the Multidimensional Health Assessment Questionnaire (MDHAQ) - neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit) | Multidimensional Health Assessment Questionnaire (MDHAQ) - patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit) | Multidimensional Health Assessment Questionnaire (MDHAQ) - review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit) | The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit) | The Multidimensional Health Assessment Questionnaire (MDHAQ) - how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in How do you feel measure was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit) | The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: 3 or more times a week (3), 1-2 times per week (2), 1-2 times per month (1), Do not exercise regularly (0), Cannot exercise due to disability/handicap (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit) | Multidimensional Health Assessment Questionnaire (MDHAQ) - fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to Fatigue is no problem and 10 to Fatigue is a major problem over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit) | Multidimensional Health Assessment Questionnaire (MDHAQ) - recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked Yes (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit) | The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Assessment of Unsolicited Adverse Events | Please refer to the safety section for further details. | Baseline to Last Follow up visit (up to 18.7 weeks) | 
| Assessment of Unsolicited Serious Adverse Events | Please refer to the safety section for further details. | Baseline to Last Follow up visit (up to 18.7 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA, Delayed-release prednisone, Immediate-release prednisone, Non-interventional