N/A
Completed N=64
A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02287610 ↗Enrolled (actual)
64
Serious AEs
1.3%
Results posted
Feb 2017
Primary outcomePrimary: Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit — -5.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit |
-5.2 | — |
| SECONDARY Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit) |
-18.9 | — |
| SECONDARY Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit) |
-0.47 | — |
| SECONDARY Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit) |
-0.86 | — |
| SECONDARY Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit) |
-0.39 | — |
| SECONDARY Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit) |
-0.62 | — |
| SECONDARY Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit) |
-5.59 | — |
| SECONDARY Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit) |
-6.28 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit) |
3.6; 14.3; 28.6; 44.6; 8.9 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit) |
5.4 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit) |
1.8 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit) |
1.8 | — |
| SECONDARY ACR-N From Baseline to Final Visit (Final Follow-up Visit) |
-15.4 | — |
| SECONDARY Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit) |
-2.06 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.05 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit) |
0.17 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.62 | — |
| SECONDARY 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) |
-0.29 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.35 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.53 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.3 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit) |
-2.5 | — |
| SECONDARY 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) |
-0.2 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.1 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.12 | — |
| SECONDARY Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit) |
-0.2 | — |
| SECONDARY Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit) |
-0.96 | — |
| SECONDARY Assessment of Unsolicited Adverse Events |
11 | — |
| SECONDARY Assessment of Unsolicited Serious Adverse Events |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02287610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.