Clinical trial NCT02287610: A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: RA
Delayed-release prednisone
Immediate-release prednisone
Non-interventional
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males and females with moderately to severely active disease who have previously received immediate-release prednisone (conventional) therapy, and prior to enrolling the SUNRAY Study, have made the joint decision (with their physicians) to convert to delayed-release prednisone (RAYOS).

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.

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

Primary outcomes:
measure: Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
Secondary outcomes:
measure: Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow-up visit (up to 18.7 weeks)
measure: Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: ACR-N From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: 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)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: 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)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Assessment of Unsolicited Adverse Events
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
measure: Assessment of Unsolicited Serious Adverse Events
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
Other outcomes:
measure: Correlation Between Vectra DA and DAS28 at Each Assessed Time Point
timeFrame: Baseline to Last Follow up visit (up to 18.7 weeks)
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Dikranian AH, Mallay R, Marshall M, Francis-Sedlak M, Holt RJ. Switching From Immediate-Release to Delayed-Release Prednisone in Moderate to Severe Rheumatoid Arthritis: A Practice-Based Clinical Study. Rheumatol Ther. 2017 Dec;4(2):363-374. doi: 10.1007/s40744-017-0075-1. Epub 2017 Aug 17.