Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial.

ABSTRACT:

Objective

To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein, in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren's syndrome (SS).

Methods

Thirty patients with primary SS were randomized to receive treatment with RSLV-132 or placebo intravenously once per week for 2 weeks, and then every 2 weeks for 12 weeks. Eight patients received placebo and 20 patients received RSLV-132 at a dose of 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Profile of Fatigue (ProF), and the Digit Symbol Substit

SUBMITTER: Posada J 

PROVIDER: S-EPMC7839752 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature