NCT07003451

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

May 26, 2025

Last Update Submit

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

Diagnostic Test: Calprotectin Level

Interventions

Calprotectin LevelDIAGNOSTIC_TEST

Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score

Rheumatoid Arthritis with ILD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 34211592BACKGROUND
  • Machahua 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

Arthritis, RheumatoidLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • waleed gamal elddin, ass. prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

waleed gamal elddin, ass. prof

CONTACT

ahmad shaddad, ass. prof

CONTACT

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

Locations