Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients
1 other identifier
observational
60
1 country
1
Brief Summary
\- Assess Krebs von den Lungen-6 (KL-6) and Calprotectin as novel biomarkers for diagnosis of ILD among Rheumatoid arthritis patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2025
CompletedFirst Posted
Study publicly available on registry
June 4, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedAugust 28, 2025
August 1, 2025
3 months
May 26, 2025
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
calprotectin level among rheumatoid arthritis patients with interstitial lung disease
calprotectin level among rheumatoid arthritis patients with interstitial lung disease
day 1
Study Arms (1)
Rheumatoid Arthritis with ILD
Rheumatoid arthritis patients with interstitial lung disease diagnosed by high resolution CT and correlated to level of biomarkers
Interventions
Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score
Eligibility Criteria
Confirmed diagnosis of Rheumatoid arthritis, age \> 18 years and confirmed diagnosis of ILD based on HRCT findings and Pulmonary function test results.
You may qualify if:
- Confirmed diagnosis of Rheumatoid arthritis, age \> 18 years.
You may not qualify if:
- Patients who refuse to participate in the study,
- Patients with evidence of worsening or exacerbation of RA over the previous 6 months,
- concomitant diagnosis of an active neoplasia, or
- patients who had previously received radiotherapy,
- End organ failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University hospital
Asyut, 71515, Egypt
Related Publications (2)
Furukawa H, Oka S, Higuchi T, Shimada K, Hashimoto A, Matsui T, Tohma S. Biomarkers for interstitial lung disease and acute-onset diffuse interstitial lung disease in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2021 Jun 18;13:1759720X211022506. doi: 10.1177/1759720X211022506. eCollection 2021.
PMID: 34211592BACKGROUNDMachahua C, Guler SA, Horn MP, Planas-Cerezales L, Montes-Worboys A, Geiser TK, Molina-Molina M, Funke-Chambour M. Serum calprotectin as new biomarker for disease severity in idiopathic pulmonary fibrosis: a cross-sectional study in two independent cohorts. BMJ Open Respir Res. 2021 Jan;8(1):e000827. doi: 10.1136/bmjresp-2020-000827.
PMID: 33451989BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
waleed gamal elddin, ass. prof
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of chest diseases
Study Record Dates
First Submitted
May 26, 2025
First Posted
June 4, 2025
Study Start
October 1, 2025
Primary Completion
January 1, 2026
Study Completion
June 1, 2026
Last Updated
August 28, 2025
Record last verified: 2025-08