A Prospective, Multi-national, Cross-sectional Study on a Risk-factor Guided Approach to Interstitial Lung Disease Screening in Patients With Rheumatoid Arthritis at Higher Risk for ILD Using High Resolution Computed Tomography

The overall aim of the study is to develop and validate a Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) clinical prediction model (screening tool) based on risk factors to guide screening for ILD in patients with RA using High Resolution Computed Tomography (HRCT).

Start Date27 Nov 2023

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT04734197

/ CompletedPhase 2

A Multicenter, Randomized, Double-Masked Study To Evaluate The Safety, Tolerability, And Efficacy Of SURF-100 Ophthalmic Solution (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination) In Subjects With Dry Eye Disease

SURF-100 is being studied for the treatment of dry eye disease. SURF-100 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.
The purpose of this research study is to see how well SURF-100 works to treat dry eye and what potential side effects there are, and to compare it with Vehicle (placebo), 0.1% mycophenolic acid (MPA) in Vehicle, 0.3% MPA in Vehicle, 0.01% betamethasone phosphate (BSP) in Vehicle, Restasis and Xiidra. This study will involve about 280-350 study participants age 18 and older at about 40 different research sites in the United States.

Start Date11 Jan 2021

Sponsor / Collaborator

Surface Ophthalmics, Inc.

NL-OMON26628

/ SuspendedNot ApplicableIIT

Intra-Operative Visualization and Treatment of Salivary Glands in Sjögren’s Syndrome by Contrast-Enhanced Ultrasound Sialendoscopy (CEUSS): Protocol for a Phase I Single-Center, Single-Arm, Exploratory Study.

Start Date31 Jul 2020

Sponsor / Collaborator-

100 Clinical Results associated with Secondary Sjögren's syndrome

100 Translational Medicine associated with Secondary Sjögren's syndrome

0 Patents (Medical) associated with Secondary Sjögren's syndrome

488

Literatures (Medical) associated with Secondary Sjögren's syndrome

01 Jun 2025·Radiology Case Reports

An atypical multiple autoimmune syndrome: A case report including myocarditis

Article

Author: El Ouafi, Noha ; Ismaili, Nabila ; Achour, Fadoua ; Tahani, Ikram

The co-occurrence of autoimmune diseases has been epidemiologically studied and has contributed to our understanding of autoimmunity. The underlying mechanisms of this syndrome remain elusive; however, its prevalence may be higher than currently documented. The co-occurrence of at least 3 autoimmune diseases in a single patient has been defined as multiple autoimmune syndrome (MAS). This syndrome can be classified into 3 categories based on the prevalence of their associations with one another: type 1, type 2, and type 3. Myocarditis is classified as type 3, and typically does not present with connective tissue involvement. This report presents the case of a young female with known autoimmune disorders: rheumatoid arthritis (RA)and secondary Sjögren's syndrome (GSJ). The patient presented with MRI-confirmed myocarditis, likely of autoimmune origin, combining the 3 conditions in an atypical presentation. An additional noteworthy aspect of this case is the uncommon occurrence of myocarditis in rheumatoid arthritis, and even more so in Sjögren's syndromes.

01 Mar 2025·Japanese Journal of Ophthalmology

Characteristics of dry eye associated with autoimmune diseases

Article

Author: Gomi, Fumi ; Yoshimura, Ayano ; Hosotani, Yuka ; Masuda, Nahomi

AbstractPurposeTo investigate the characteristics of dry eye in patients with autoimmune disease.Study DesignRetrospective clinical study.MethodsTwo hundred and fifty-two eyes from 252 patients (12 men and 240 women, mean age 59.8 ±15.2) with autoimmune disease and dry eye were enrolled. Patients were divided into three groups: primary Sjogren’s syndrome, secondary Sjogren’s syndrome, and autoimmune disease without Sjogren’s syndrome.ResultsAmong all cases, the mean fluorescein breakup time (FBUT) was 2.7 ± 1.6 s, the van Bijesterveld corneal score was 0.8 ± 0.8, the conjunctival score was 1.5 ± 1.7; and the Schirmer 1 test value was 8.4 ± 8.2 mm. Among all cases, the fluorescein breakup pattern (FBUPs) was tear-deficiency-type dry eye in 43% of eyes (area 11%, line 32%), and short FBUT-type dry eye in 57% (dimple 31%, spot 10%, random 16%). Conjunctival scores showed significant positive correlations with anti-SS-A and anti-SS-B antibody titers in the primary and secondary Sjogren’s syndrome groups.ConclusionMore than half of the dry eyes associated with autoimmune diseases were short FBUT-type. Patients with autoimmune disease should be aware of dry eye, even without a diagnosis of Sjogren’s syndrome.

26 Jan 2025·Cureus

Back Pain as a Clue to Spinal Cord Involvement in Sjögren's Syndrome: An Uncommon Case

Article

Author: Alves, Hugo ; Vasconcelos, Mafalda ; Moreira, Ana Patrícia ; Santos, André ; Espírito Santo, João

Sjögren's syndrome (SS) is an autoimmune disease with systemic manifestations. Neurological manifestations of SS include vasculitis, dorsal ganglionitis, demyelination, myelitis, myeloradiculitis, meningoencephalitis, cognitive dysfunction, and autonomic dysfunction mediated by antibodies. We present a case of a 65-year-old woman with a significant medical history of rheumatoid arthritis and secondary Sjögren's syndrome, diagnosed 20 years prior, and treated non-Hodgkin lymphoma. She presented to the emergency department with progressive lower back pain, radiating to the lower limbs for the past five months, along with sensory loss, weakness in the lower limbs, urinary retention, fecal incontinence, and recurrent fever. On examination, she had grade 4 paraparesis predominantly in the proximal muscles, with suspended thermoalgesic sensation from D6-11 and areas of allodynia in L5-S1, abolished deep tendon reflexes in the lower limbs, and absent bilateral plantar reflexes. MRI revealed a longitudinally extensive spinal cord lesion (from D4 to the conus medullaris) with T2 hyperintensity, contrast enhancement, and meningeal and cauda equina root thickening. Lumbar puncture showed lymphocytosis, hypoglycorrhachia, and hyperproteinorrachia, suggestive of lymphocytic meningitis. Microbiology, immunophenotyping, anti-aquaporin-4 antibodies, angiotensin-converting enzyme (ACE), calcium, and urinary calcium levels were normal. Meningeal biopsy at D10 showed an unspecific mononuclear inflammatory process. She received pulses of methylprednisolone but continued to experience paraparesis, fever, asthenia, and new vertebral joint arthritis/synovitis at L4-L5, leading to the initiation of cyclophosphamide treatment with progressive improvement. Sjögren's syndrome has a wide range of manifestations and can involve multiple systems. Spinal cord involvement is rare and presents diagnostic dilemmas between infectious causes, other autoimmune diseases, and neuromyelitis optica spectrum disorders.

News (Medical) associated with Secondary Sjögren's syndrome

25 Jul 2023

·www.prnewswire.com

RemeGen's Telitacicept Shows Significant Promise in Phase II Trial for Primary Sjogren's Syndrome: Findings Published in Prestigious Rheumatology Journal

YANTAI, China, July 25, 2023 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (HKG: 9995, SHA: 688331), a fully-integrated commercial-stage biotechnology company, has announced that their Phase II clinical study of telitacicept (RC18) for the treatment of Primary Sjögren's Syndrome (pSS) in adults has been published in top international medical journal Rheumatology. Rheumatology is the official journal of the British Society for Rheumatology which is published by Oxford University Press. The journal is currently included in 27 international databases and is a top journal in this field with an impact factor of 7.046 in 2021. The study, led by Professor Zeng Xiaofeng from the Department of Rheumatology and Immunology in Peking Union Medical College Hospital, was a randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of telitacicept in treating adult pSS patients. A total of 42 subjects were included, with three groups randomly receiving subcutaneous injections of placebo, 160mg of telitacicept, and 240mg of telitacicept once a week for 24 weeks. The study found significant improvements in EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) scores, with mean changes from a baseline of 0.6 ± 4.55, -3.3 ± 2.73, and -1.3 ± 4.14 in the placebo, 160mg, and 240mg groups, respectively. Using mixed model for repeated measures (MMRM), the change in ESSDAI was significantly lower compared to placebo for the 160mg group at week 24 (P value=0.002). Telitacicept treatment was well-tolerated, with no deaths or serious adverse events reported. The drug demonstrated promising clinical benefits, improving ESSDAI scores, MFI-20, and reducing immunoglobulin levels. Overall, telitacicept showed great potential as a breakthrough treatment for pSS. "RemeGen is delighted with these published breakthrough findings that offer new hope for pSS treatment. As a new drug with significant potential, telitacicept Phase II clinical study data has been published in top international journals, which is major proof of our research and development capabilities. We fully expect telitacicept to enter the market imminently, bringing much-needed new hope to patients all over the world," said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen. pSS is an autoimmune disorder primarily affecting the mucous membranes and moisture-secreting glands, causing diminished tear and saliva production, resulting in dry mouth and eyes. Secondary Sjögren's syndrome is characterized by accompanying autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). pSS involves highly active B cells, with B cell pathways playing a crucial role in its development. Currently, there is no satisfactory evidence-based treatment for pSS, and existing drugs are often empirical or based on similar conditions. Telitacicept, a novel fully human TACI-Fc fusion protein, shows promise in inhibiting B cell maturation and reducing autoantibody production, offering significant potential disease activity control. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: About Telitacicept (RC18) Telitacicept (RC18, Brand Name: 泰爱®) is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. It was granted conditional marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in March 2021. SOURCE RemeGen Co., Ltd

Phase 2Clinical ResultDrug Approval

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