Overview
A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis
Status:
Completed
Completed
Trial end date:
2015-10-01
2015-10-01
Target enrollment:
0
0
Participant gender:
All
All
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.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Horizon Pharma Ireland, Ltd., Dublin IrelandTreatments:
Prednisone
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