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

NCT02287610 | Completed Results

• 1 other identifier: HZ-PRE-NIS02
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

RA; Delayed-release prednisone; Immediate-release prednisone; Non-interventional

Outcome Measures

Primary Outcomes (1)

• Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit

  Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to "Not Severe at All" and 100 to "Extremely Severe". This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up.

  Baseline to Last Follow up visit (up to 18.7 weeks)

Secondary Outcomes (28)

• Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)

  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)

  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)

  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)

  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)

  Baseline to Last Follow up visit (up to 18.7 weeks)

Other Outcomes (1)

• Correlation Between Vectra DA and DAS28 at Each Assessed Time Point

  Baseline to Last Follow up visit (up to 18.7 weeks)

Interventions

RAYOS (delayed-release prednisone) DRUG

Physicians may prescribe any dosage of RAYOS based on what is appropriate for the treatment of the patient's condition as determined by performing standard of care assessments.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Patient is unwilling to participate in the non-interventional study

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• 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.

  PMID: 28819927 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Mike Marshall, PharmD
• Organization: Horizon Pharma Ireland, Ltd.

clinicaltrials@horizonpharma.com

224-383-3000

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 18, 2024
• Results First Posted: February 3, 2017

Record last verified: 2024-11