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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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RAYOS (delayed-release prednisone)

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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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.

Reference Type DERIVED

PMID: 28819927 (View on PubMed)

Other Identifiers

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HZ-PRE-NIS02

Identifier Type: -

Identifier Source: org_study_id