The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach

NCT01940094 ↗

Phase 3 Completed 159 enrolled University of Pennsylvania National Center for Advancing Translational Sciences (NCATS) · collab National Heart, Lung, and Blood Institute (NHLBI) · collab National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab Office of Rare Diseases (ORD) · collab Rare Diseases Clinical Research Network · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.

Timeline

Start: 2014-02
Primary completion: 2024-12
Completion: 2024-12

Publications

Cronholm PF, Applequist J, Krischer J, Fontenot E, Davis T, Burroughs C, McAlear CA, Borchin R, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg SR, Merkel PA; Vasculitis Clinical Research Consortium. A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research. BMC Med Res Methodol. 2024 Oct 18;24(1):244. doi: 10.1186/s12874-024-02352-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisone	Other / unclassified	0 mg	—
Subject	Prednisone	Other / unclassified	5 mg	—

The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach

Summary

Timeline

Publications

Drugs

Indications