NCT04356066

Brief Summary

Rheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing symmetric pain, stiffness, swelling, and limited motion and function of multiple joints, its fibro inflammatory manifestations may develop in other organs.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

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

January 17, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

April 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

January 17, 2020

Last Update Submit

April 20, 2020

Conditions

Interstitial Lung Disease in Patients With Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis

    serum level

    2 years

Study Arms (1)

Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise

OTHER

* History taking: age, sex, disease duration, history of present illness, drug intake, past and family history. * Physical examination including thorough clinical examination. * Health assessment questionnaire-disability index (HAQ-DI): It is used as a subjective measure of physical function of RA patients (Pincus et al., 1983). There are 20 items in 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities (Jessica et al., 2018).

Diagnostic Test: serum cxcl10 by ELISA

Interventions

serum cxcl10 by ELISADIAGNOSTIC_TEST

serum sample

Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult rheumatoid arthritis patients who fulfilled the 2010 American College of Rheumatology/European league against rheumatism criteria for the classification of Rheumatoid Arthritis.
  • Adult rheumatoid arthritis patients with interstitial lung disease.

You may not qualify if:

  • Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis and inflammatory bowel disease).
  • Individuals with hepatitis, Rhinovirus infection, cerebral malaria.
  • Individuals with colorectal carcinoma, syndrome of frailty, vetiligo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Chen J, Doyle TJ, Liu Y, et al. Biomarkers of rheumatoid arthritis-associated interstitial lung disease. Arthritis Rheumatol. 2015;67(1):28-38. doi:10.1002/art.38904 2. Richards TJ, Eggebeen A, Gibson K, et al. Characterization and peripheral blood biomarker assessment of anti-Jo-1 antibody-positive interstitial lung disease. Arthritis Rheum. 2009;60(7):2183-2192. doi:10.1002/art.24631 3. Amigues I, Ramadurai D, Swigris JJ. Current Perspectives On Emerging Biomarkers For Rheumatoid Arthritis-Associated Interstitial Lung Disease. Open Access Rheumatol. 2019;11:229-235. Published 2019 Oct 15. doi:10.2147/OARRR.S166070 4. Vij R, Strek ME. Diagnosis and treatment of connective tissue disease-associated interstitial lung disease. Chest. 2013;143(3):814-824. doi:10.1378/chest.12-0741 5. Castelino FV, Varga J. Interstitial lung disease in connective tissue diseases: evolving concepts of pathogenesis and management. Arthritis Res Ther. 2010;12(4):213. doi:10.1186/ar3097 6. Laragione T, Brenner M, Sherry B, Gulko PS. CXCL10 and its receptor CXCR3 regulate synovial fibroblast invasion in rheumatoid arthritis. Arthritis Rheum. 2011;63(11):3274-3283. doi:10.1002/art.30573 7. Gao B, Lin J, Jiang Z, et al. Upregulation of chemokine CXCL10 enhances chronic pulmonary inflammation in tree shrew collagen-induced arthritis. Sci Rep. 2018;8(1):9993. Published 2018 Jul 3. doi:10.1038/s41598-018-28404-y

    RESULT

Central Study Contacts

Naima Mohamed Mostafa, professor doctor

CONTACT

01223947372naimamohamed21@yahoo.com

Samar Hassanein Goma, Ass Prof

CONTACT

01061828586Samarhassanein2010@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 17, 2020

First Posted

April 22, 2020

Study Start

December 19, 2020

Primary Completion

January 19, 2021

Study Completion

January 19, 2022

Last Updated

April 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share