Interstitial Lung Disease in Patients With Rheumatoid ArthritisNCT04356066
CXCL10 As a Biomarker Of ILD in Patients WithRA
A study testing serum cxcl10 by ELISA in people with Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease in Patients With Rheumatoid Arthritis
- What is being tested?
- serum cxcl10 by ELISA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2020to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
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.
Read the detailed description
Rheumatoid arthritis is complicated by lung manifestations, such as interstitial lung disease which is the most common cause of morbidity and mortality in rheumatoid arthritis patients. Rheumatoid arthritis-interstitial lung disease is a progressive fibrotic disease of the lung parenchyma that includes a broad spectrum of disorders such as nonspecific interstitial pneumonia, usual interstitial pneumonia , desquamative interstitial pneumonia, cryptogenic organizing pneumonia, diffuse alveolar damage, acute interstitial pneumonia, and lymphocytic interstitial pneumonia . Rheumatoid arthritis-interstitial lung disease in which available data indicate that dysregulated inflammatory cascades can elaborate a host of cytokines, chemokines, and growth factors that collectively promote epithelial and endothelial cell damage, angiogenesis, fibroblast differentiation/proliferation, and lung fibrosis . Given the clinical implications of putative signaling cascades involved in these processes, biomarkers that can be used to clarify disease pathogenesis and identify factors governing disease progression are clearly needed .
- Being tested
- serum cxcl10 by ELISA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum cxcl10 by ELISADiagnostic test
serum sample
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: serum cxcl10 by ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
serum level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start19 Dec 2020 (estimated)
- Primary completion19 Jan 2021 (estimated)
- Study completion19 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease in Patients With Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzahraa Awny Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356066
- Sponsor's protocol ID
- zahraa
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04356066
- Acronym / sponsor ID
- zahraa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Dec 2020 (estimated)
- Primary completion
- 19 Jan 2021 (estimated)
- Study completion
- 19 Jan 2022 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rheumatoid arthritis is complicated by lung manifestations, such as interstitial lung disease which is the most common cause of morbidity and mortality in rheumatoid arthritis patients. Rheumatoid arthritis-interstitial lung disease is a progressive fibrotic disease of the lung parenchyma that includes a broad spectrum of disorders such as nonspecific interstitial pneumonia, usual interstitial pneumonia , desquamative interstitial pneumonia, cryptogenic organizing pneumonia, diffuse alveolar damage, acute interstitial pneumonia, and lymphocytic interstitial pneumonia . Rheumatoid arthritis-interstitial lung disease in which available data indicate that dysregulated inflammatory cascades can elaborate a host of cytokines, chemokines, and growth factors that collectively promote epithelial and endothelial cell damage, angiogenesis, fibroblast differentiation/proliferation, and lung fibrosis . Given the clinical implications of putative signaling cascades involved in these processes, biomarkers that can be used to clarify disease pathogenesis and identify factors governing disease progression are clearly needed .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise | Other | Diagnostic Test: serum cxcl10 by ELISA* 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum cxcl10 by ELISAserum sample | Diagnostic test | Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise |
Primary outcome
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Time frame: 2 years
serum level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Results publication1. 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing serum cxcl10 by ELISA in people with Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naima Mohamed Mostafa, professor doctor (01223947372, naimamohamed21@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04356066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.