N-acetylcysteine for Primary Sjögren's Syndrome

NCT04793646 | Completed

• 1 other identifier: 24088719.4.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

N-acetylcysteine (NAC) allows the elimination of reactive oxygen species (ROSs) and it has an anti-inflammatory effect. For this reason, NAC has been used and researched for treatment of several diseases, such as autoimmune diseases. In these diseases there are a process of oxidative stress due to chronic inflammation, which promotes an imbalance between ROSs levels and the cellular capacity to eliminate reactive intermediates and repair the resulting damage through antioxidants. The imbalance between the production of free radicals from oxygen and antioxidant species may also be involved in the pathogenesis of primary Sjögren's syndrome (pSS). In fact, increased levels of oxidative stress markers were detected in biopsy samples from minor salivary glands in these patients. Treatment of pSS is not well established and it is also not able to modify the evolution of the disease, being often only symptomatic. In addition, there is little data in the literature regarding the true efficacy of NAC in the treatment of pSS and the few existing studies have evaluated heterogeneous populations (including patients with other causes of sicca syndrome) and validated instruments to measure the symptom index and disease activity were not use in these previous studies. Thus, the present randomized double-blind clinical study aims to evaluate the efficacy of NAC in the control of sicca syndrome symptoms in a homogeneous population of patients with pSS (not only regarding the classification criteria, but also regarding the low rate of systemic disease activity at study inclusion) through tests widely accepted in the literature. Additionally, the investigators will study the possible role of NAC on oxidative stress in peripheral blood and saliva of these patients.

Conditions

Sjögren Syndrome; Sicca Syndrome

Outcome Measures

Primary Outcomes (1)

• EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

  Comparative analysis of ESSPRI values

  3 months

Secondary Outcomes (1)

• Xerostomia inventory

  3 months

Study Arms (2)

N-acetylcysteine syrup

ACTIVE COMPARATOR

Thirty pSS patients

Drug: N-acetylcysteine syrup

Placebo syrup

PLACEBO COMPARATOR

Thirty pSS patients

Drug: Placebo syrup

Interventions

N-acetylcysteine syrup DRUG

N-acetylcysteine syrup 600 mg (15 mL) twice a day for 3 months

Also known as: N-acetylcysteine

N-acetylcysteine syrup

Placebo syrup DRUG

Placebo syrup 15 mL twice a day for 3 months

Also known as: Placebo

Placebo syrup

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreement to participate in the study according to signed informed consent.
• Filling the pSS classification criteria.
• Absence of other autoimmune associates systemic diseases.
• EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) \<= 5.

You may not qualify if:

• Diabetes, sarcoidosis, previous history of head and neck radiotherapy or iodine therapy, positive serologies for HIV, hepatitis B and C, graft versus host disease, IgG4 (immunoglobulin G4) related disease, and current use of antidepressants tricyclics.
• Current use of biological therapy.
• Current smoking.
• Alcoholism.
• Liver cirrhosis and chronic kidney disease.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

Location

Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (8)

• Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjogren's Syndrome. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. doi: 10.1136/ard.61.6.554.

  PMID: 12006334 BACKGROUND

• Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjogren's syndrome: A consensus and data-driven methodology involving three international patient cohorts. Ann Rheum Dis. 2017 Jan;76(1):9-16. doi: 10.1136/annrheumdis-2016-210571. Epub 2016 Oct 26.

  PMID: 27789466 BACKGROUND

• Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.

  PMID: 21345815 BACKGROUND

• Seror R, Ravaud P, Bowman SJ, Baron G, Tzioufas A, Theander E, Gottenberg JE, Bootsma H, Mariette X, Vitali C; EULAR Sjogren's Task Force. EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis. 2010 Jun;69(6):1103-9. doi: 10.1136/ard.2009.110619. Epub 2009 Jun 28.

  PMID: 19561361 BACKGROUND

• Walters MT, Rubin CE, Keightley SJ, Ward CD, Cawley MI. A double-blind, cross-over, study of oral N-acetylcysteine in Sjogren's syndrome. Scand J Rheumatol Suppl. 1986;61:253-8.

  PMID: 3296153 BACKGROUND

• Ramos-Casals M, Brito-Zeron P, Siso-Almirall A, Bosch X. Primary Sjogren syndrome. BMJ. 2012 Jun 14;344:e3821. doi: 10.1136/bmj.e3821. No abstract available.

  PMID: 22700787 BACKGROUND

• Danilovic A, Lucon AM, Srougi M, Shimizu MH, Ianhez LE, Nahas WC, Seguro AC. Protective effect of N-acetylcysteine on early outcomes of deceased renal transplantation. Transplant Proc. 2011 Jun;43(5):1443-9. doi: 10.1016/j.transproceed.2011.02.020.

  PMID: 21693215 BACKGROUND

• D'Agostino Gennari J, Deveza GBH, Ribeiro CT, Seguro AC, Aikawa NE, Shimizu MHM, Leon EP, Guedes LKN, Kupa LVK, Silva CAA, Bonfa E, Pasoto SG. Efficacy of N-acetylcysteine for treating dryness symptoms of Sjogren's disease: randomised placebo-controlled double-blind clinical study. Clin Exp Rheumatol. 2024 Dec;42(12):2427-2436. doi: 10.55563/clinexprheumatol/dmd5dv. Epub 2024 Sep 27.

  PMID: 39360368 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sandra Pasoto, MD, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of identical bottles of N-acetylcysteine and placebo syrup
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind controlled study of N-acetylcysteine for treatment of dryness symptoms due to primary Sjogren's syndrome

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: April 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: January 21, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)