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

Amgen0 sites75 target enrollmentNovember 2014

ConditionsRheumatoid Arthritis

DrugsRAYOS (delayed-release prednisone)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Amgen
Enrollment: 75
Primary Endpoint: Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

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. Study with completed results acquired from Horizon in 2024.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

October 2015

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit

Time Frame: Baseline to Last Follow up visit (up to 18.7 weeks)

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.

Secondary Outcomes

Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(Baseline to Last Follow up visit (up to 18.7 weeks))
ACR-N From Baseline to Final Visit (Final Follow-up Visit)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(Baseline to Last Follow up visit (up to 18.7 weeks))
Assessment of Unsolicited Adverse Events(Baseline to Last Follow up visit (up to 18.7 weeks))
Assessment of Unsolicited Serious Adverse Events(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)(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)(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)(Baseline to Last Follow up visit (up to 18.7 weeks))