Trial reportClinical rheumatology2016
A phase II investigator-initiated pilot study with low-dose cyclosporine A for the treatment of articular involvement in primary Sjögren's syndrome.
Trial report in Clinical rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01693393 (A Phase II Pilot-Study With Low-dose Sandimmun Optoral), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
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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 II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Clinical practice guideline for the treatment of Sjögren's disease through off-label drug use in China (English edition).Clinical rheumatology · 2026Guideline
- Development and Application of the Placebo Response Model in Clinical Trials for Primary Sjögren's Syndrome.Frontiers in immunology · 2021Pooled it
- Pooled it
- Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjögren Syndrome: A Randomized Clinical Trial.JAMA network open · 2022Trial
- Identification and verification of inflammatory biomarkers for primary Sjögren's syndrome.Clinical rheumatology · 2024Article
- Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.Expert opinion on emerging drugs · 2023Review
- Osteoarthritis or arthritis? Toward understanding of primary Sjögren's syndrome patients with arthralgia.Journal of orthopaedic surgery and research · 2023Article
- Cardiovascular Involvement in Sjögren's Syndrome.Frontiers in immunology · 2022Review
- The Role of Calcium-Calcineurin-NFAT Signaling Pathway in Health and Autoimmune Diseases.Frontiers in immunology · 2020Review
- Advances in the diagnosis and treatment of Sjogren's syndrome.Clinical rheumatology · 2018Review
- Primary Sjögren's syndrome: Extraglandular manifestations and hydroxychloroquine therapy.Clinical rheumatology · 2017Article
- Salivary gland ultrasonography as a predictor of clinical activity in Sjögren's syndrome.PloS one · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledThis study aims to investigate the efficacy and safety of low-dose cyclosporine A (CyA) in patients with primary Sjögren's syndrome (pSS) and articular involvement. This phase II open-label clinical study included 30 patients meeting the American-European Consensus group criteria for pSS with active joint involvement under stable symptomatic therapy. Treatment consisted of approximately 2 mg kg(-1) body weight of CyA day(-1) over a period of 16 weeks. The primary endpoint was defined as a reduction in the number of painful and/or swollen joints at end of treatment (EOT). Secondary endpoints included the changes in general health, sicca symptoms, European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI), arthrosonography, and safety profile. At baseline (BL), the mean number of tender joints (68 count) was 16.2 (±13.2) and at EOT 10.4 (±11.9; p = 0.002). The mean number of swollen joints (66 counts) was reduced from 3.2 (±3.3) at BL to 1.3 (±3.2) at EOT (p < 0.001). Overall, 21 (70 %) and 13 (43.3 %) patients had a reduction of two or more tender and swollen joints, respectively, in the 68/66 joint counts. The disease activity score (DAS28) showed a statistically and clinically meaningful decrease over the 16-week period of treatment. Treatment was well tolerated, and adverse events were consistent with the known safety profile of CyA (e.g., hypertension, headache). In this pilot study, promising effects of low-dose CyA treatment on articular involvement were observed in patients with pSS justifying further controlled studies in this indication. No new or unexpected safety observations were made.
trial registrationLow-Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS), ClinicalTrials.gov Identifier: NCT01693393 .
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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 OpenQuestion graph.