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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02287610
Date of registration: 06/11/2014
Prospective Registration: Yes
Primary sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
Public title: A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis SUNRAY
Scientific 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
Date of first enrolment: November 2014
Target sample size: 75
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02287610
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: RAYOS (delayed-release prednisone)
Primary Outcome(s)
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)]
Secondary Outcome(s)
ACR-N From Baseline to Final Visit (Final Follow-up Visit) [Time Frame: Baseline to Last Follow up visit (up to 18.7 weeks)]
Assessment of Unsolicited Adverse Events [Time Frame: Baseline to Last Follow up visit (up to 18.7 weeks)]
Assessment of Unsolicited Serious Adverse Events [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: Baseline to Last Follow up visit (up to 18.7 weeks)]
Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: Baseline to Last Follow up visit (up to 18.7 weeks)]
Secondary ID(s)
HZ-PRE-NIS02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 03/02/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02287610
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