A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis (SUNRAY)

Amgen

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: RAYOS (delayed-release prednisone)

Study type: Observational

Funder types: Industry

Identifiers

NCT02287610

HZ-PRE-NIS02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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