Dataset Information

Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar^® Gel) for Persistently Active Systemic Lupus Erythematosus.

ABSTRACT:

Introduction

We assessed patient-reported outcomes from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar^® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.

Methods

The trial enrolled adults with active SLE and moderate-to-severe rash and/or arthritis despite use of stable glucocorticoids (7.5 mg/day to 30 mg/day prednisone equivalent), antimalarials, and nonsteroidal anti-inflammatory drugs for ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day through week 4, then twice weekly through week 24. Primary analyses ev

SUBMITTER: Askanase AD

PROVIDER: S-EPMC7991053 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Dataset Information

Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar^® Gel) for Persistently Active Systemic Lupus Erythematosus.

Introduction

Methods

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus.

Introduction

Methods

OmicsDI is part of the ELIXIR infrastructure

Tweets

Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar^® Gel) for Persistently Active Systemic Lupus Erythematosus.