Trial reportArthritis & rheumatology (Hoboken, N.J.)2021
Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren's Syndrome: A Randomized Clinical Trial.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06440525 (A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Pooled it
- Pooled it
- Development and Application of the Placebo Response Model in Clinical Trials for Primary Sjögren's Syndrome.Frontiers in immunology · 2021Pooled it
- Revisiting the JOQUER trial: stratification of primary Sjögren's syndrome and the clinical and interferon response to hydroxychloroquine.Rheumatology international · 2021Trial
- Efficacy and safety of pharmacological treatment for Sjögren's disease: a network meta-analysis.Zeitschrift fur Rheumatologie · 2026Article
- [Current treatment, foreseeable newcomer and new treatment approaches for Sjögren's disease].Zeitschrift fur Rheumatologie · 2026Review
- Fatigue in Sjögren's Disease - Integrating Biomedical and Psychosocial Aspects: A Narrative Review.Rheumatology and therapy · 2026Review
- Evolving treatments for Sjögren disease: current approaches and emerging targets.Internal medicine journal · 2026Review
- Molecular Insights into Oral Manifestations in Sjögren's Disease.International journal of molecular sciences · 2026Review
- Sjögren's Syndrome: Epidemiology, Classification Criteria, Molecular Pathogenesis, Diagnosis, and Treatment.MedComm · 2025Review
- Ribonuclease activity undermines immune sensing of naked extracellular RNA.Cell genomics · 2025Article
- Article
- FatiguE in Sjögren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA).BMJ open sport & exercise medicine · 2025Article
- Review
- Update on the pathophysiology and treatment of primary Sjögren syndrome.Nature reviews. Rheumatology · 2024Review
- Type I Interferons in Systemic Autoimmune Rheumatic Diseases: Pathogenesis, Clinical Features and Treatment Options.Mediterranean journal of rheumatology · 2024Review
- Research hotspots and emerging trends in the treatment of Sjogren's syndrome: A bibliometric analysis from 1900 to 2022.Heliyon · 2024Article
- Improved Fatigue Management in Primary Sjögren's Syndrome: A Retrospective Analysis of the Efficacy of Methotrexate in Chinese Patients.Journal of inflammation research · 2024Article
- Emerging biologic frontiers for Sjogren's syndrome: Unveiling novel approaches with emphasis on extra glandular pathology.Frontiers in pharmacology · 2024Review
- Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.Expert opinion on emerging drugs · 2023Review
Corrections and comments
- Commented on byReply.2021
- Commented on by
Authors and funding
12 authors at 7 institutions in 2 countries.
Funding
Abstract
objectiveTo 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).
methodsThirty 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 Substitution Test (DSST).
resultsPatients randomized to receive RSLV-132 experienced clinically meaningful improvements in the ESSPRI score (P = 0.27), FACIT-F score (P = 0.05), ProF score (P = 0.07), and DSST (P = 0.02) from baseline to day 99, whereas patients who received placebo showed no changes in any of these clinical efficacy measures. This improvement was significantly correlated with increased expression of selected interferon-inducible genes (Pearson's correlations, each P < 0.05).
conclusionAdministration of RSLV-132 improved severe fatigue, as determined by 4 independent patient-reported measures of fatigue, in patients with primary SS.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.