"Matrix Metalloproteinases 7 and 9 in Rheumatoid Arthritis Patients With Interstitial Lung Disease"

NCT07173582 | Not Yet Recruiting

• 1 other identifier: Matrix Metalloproteinase in RA
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This case control study will be done at Rheumatology Department, Assiut University Hospital. It will include RA patients fulfilling the American College of Rheumatology and European League against Rheumatism (ACR / EULAR) 2010 classification criteria. Aim of the study

• To assess the matrix metalloproteinase 7 and 9 (MMP7,9) as a screening tool for interstitial lung disease in rheumatoid arthritis patients and to assess for correlation with RA-disease activity.
• To investigate whether certain MMPs could be potential biomarkers reflecting the lung fibrotic process in RA patients.
• To assess the capillaroscopy changes in RA and RA-ILD.
• To detect correlation between MMPs and capillaroscopic changes in RA patients. This case control study will be done at Rheumatology Department, Assiut University Hospital. It will include RA patients fulfilling the American College of Rheumatology and European League against Rheumatism (ACR / EULAR) 2010 classification criteria. The patients will be divided into 3 groups: Group (1): RA patients with ILD. Group (2): RA patients without ILD Group (3): Healthy controls All patients will be subjected to: A- Complete medical history: Detailed medical history will be taken including demographic data (age, sex, disease duration, morning stiffness, joint involvement, smoking, habits of medical importance), articular and extra articular manifestations. Detailed respiratory manifestations as (dyspnea, cough, chest wheeze, others) B- Clinical examination:
• General and local rheumatological examination.
• Local chest examination (inspection, palpation, percussion, auscultation).
• Assessment of RA disease activity using DAS 28 ESR. Score interpretation \<2.6 suggests disease remission. 2.6-3.2 suggests low disease activity 3.2-5.1 suggests moderate disease activity \>5.1 suggest high disease activity C- Laboratory investigations: Peripheral venous blood samples for CBC, C-reactive protein, erythrocyte sedimentation rate, antibody status. D- Radiology and PFT: PFTs and HRCT chest patterns will be done for patients. E- MMP measurement: Serum samples will be collected at the time of registry enrollment, MMP 7 and 9 concentrations will be measured using enzyme-linked immunosorbent assas. This ELISA kit uses the Sandwich-ELISA principle.

Conditions

Rheumatoid Arthritis (RA)

Keywords

MMPs RA ILD

Outcome Measures

Primary Outcomes (1)

• 1. Creation of a statistical relation between Matrix Metalloprotienases 7 and 9 concentrations and the severity of the RA. 2. Creation of a statistical relation between MMPs concentrations and development of ILD.

  1\. Creation of a statistical relation between MMPs concentrations and the severity of the RA. 2. Creation of a statistical relation between MMPs concentrations and development of ILD. Secondary Outcome Measure

  at time of enrollement

Secondary Outcomes (1)

• Nailfold capillaroscopic patterns in rheumatoidarthritis patients

  1 year

Other Outcomes (1)

• relation of nail-fold capillaroscopy and RA activity and relation to developing ILD

  1 year

Study Arms (1)

Group (1): RA with ILD. Group (2): RA without ILD or chest symptoms. Group (3):Healthy controls.

All patients will be subjected to: A- Complete medical history: B- Clinical examination: C- Laboratory investigations: D- Radiology and PFT: E- MMP measurement: F. The capillaroscopy procedure

Diagnostic Test: Serum samples will be collected at the time of registry enrollment, MMP 7 and 9 concentrations will be measured using enzyme-linked immunosorbent assays.

Interventions

Serum samples will be collected at the time of registry enrollment, MMP 7 and 9 concentrations will be measured using enzyme-linked immunosorbent assays. DIAGNOSTIC_TEST

All patients will be subjected to: A- Complete medical history: including demographic data (age, sex, disease duration, morning stiffness, joint involvement, smoking, habits of medical importance), articular and extra articular manifestations. Detailed respiratory manifestations. B- Clinical examination: * General and local rheumatologic examination. * Local chest examination (inspection, palpation, percussion, auscultation). * Assessment of RA disease activity using DAS 28 ESR. C- Laboratory investigations: CBC, C-reactive protein, erythrocyte sedimentation rate, antibody status. D- Radiology and PFT: PFTs and HRCT chest patterns will be done for patients. E- MMP measurement: MMP 7 and 9 concentrations will be measured using enzyme-linked immunosorbent assays. F. The capillaroscopy procedure

Also known as: Radiology and PFT:, Nail fold capillaroscopy

Group (1): RA with ILD. Group (2): RA without ILD or chest symptoms. Group (3):Healthy controls.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This case control study will be done at Rheumatology Department, Assiut University Hospital. It will include RA patients fulfilling the American College of Rheumatology and European League against Rheumatism (ACR / EULAR) 2010 classification criteria. All patients will be followed by treating rheumatologists per routine clinical care. The patients will be divided into 3 groups: Group (1): RA patients with ILD. Group (2): RA patients without ILD Group (3): Healthy controls

You may qualify if:

• Age \>18. 2- RA diagnosis according (ACR / EULAR) 2010.

You may not qualify if:

• Age \<18 years.
• Other connective tissue diseases (systemic sclerosis, systemic Lupus and Mixed connective tissue disease)
• Malignancy
• Another chest presentation
• Patient refuse
• Patients with recent nail trauma
• Patients with heavy manual activities
• Poor nailfold hygiene
• Congestive heart failure
• Individuals unable to cooperate during the nailfold capillaroscopic examination.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, 71111, Egypt

Location

Related Publications (2)

• Duarte AC, Porter JC, Leandro MJ. The lung in a cohort of rheumatoid arthritis patients-an overview of different types of involvement and treatment. Rheumatology (Oxford). 2019 Nov 1;58(11):2031-2038. doi: 10.1093/rheumatology/kez177.

  PMID: 31089697 BACKGROUND

• Raghu G, Remy-Jardin M, Richeldi L, Thomson CC, Inoue Y, Johkoh T, Kreuter M, Lynch DA, Maher TM, Martinez FJ, Molina-Molina M, Myers JL, Nicholson AG, Ryerson CJ, Strek ME, Troy LK, Wijsenbeek M, Mammen MJ, Hossain T, Bissell BD, Herman DD, Hon SM, Kheir F, Khor YH, Macrea M, Antoniou KM, Bouros D, Buendia-Roldan I, Caro F, Crestani B, Ho L, Morisset J, Olson AL, Podolanczuk A, Poletti V, Selman M, Ewing T, Jones S, Knight SL, Ghazipura M, Wilson KC. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2022 May 1;205(9):e18-e47. doi: 10.1164/rccm.202202-0399ST.

  PMID: 35486072 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nesreen M. Abdelbary, MD

  assiut univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nesreen m. Abdelbary, MD

CONTACT

0201141063238; mohamed.saad85@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: "Matrix Metalloproteinases 7 and 9 in Rheumatoid Arthritis patients with Interstitial Lung disease and its relation to disease activity

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

EG (1)