Rheumatoid ArthritisNCT05105230
Soluble Programmed Death 1 (sPD1) is a Diagnostic Biomarker of ILD in Patients With Rheumatoid Arthritis Disease
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
1. Evaluate the levels of serum (sPD1) in RA patients with ILD and those without. 2. Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation of RA Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- soluble programmed death 1biomarker
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Aug 2023
- Phase
- Observational
- 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 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: 1. Adult RA Patients 2. Adult RA patients with ILD 3. Adult healthy control
Who may be able to join
- Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA (7).
- Adult RA patients with ILD (Nonspecific idiopathic interstitial pneumonia more than 16 years old).
Who cannot join
- Patients with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa sarcoidosis, dermatomyositis, scleroderma, spondylarthritis and inflammatory bowel disease).
- RA patients with lung affection other than ILD
- Patients with malignant tumors
- Patients with active infection
- Patients with severe heart, lung, and kidney dysfunction
- Patients with tuberculosis, pulmonary infection, chronic obstructive pulmonary disease, bronchiectasis, lung tumor, and pneumoconiosis disease.
- Uses of drugs (other than RA medication) known to cause ILD such as antimicrobial agents (Sulphonamide), cardiovascular agents (amiodarone) and Bromocriptine.
Trial locations and contacts
No sites are listed yet.
About this study
- Evaluate the levels of serum (sPD1) in RA patients with ILD and those without.
- Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation of RA
Read the detailed description
Rheumatoid arthritis is a chronic autoimmune disease that is characterized by a systemic inflammatory state that affects joints and other organs .
There are many types of RA-related pulmonary diseases. RA-related pulmonary diseases include airway disease such as bronchiolitis. There are interstitial lung diseases that include non-specific interstitial pneumonitis and usual interstitial pneumonia .
The pathogenesis of RA is multifactorial with contributions from genetic and environmental factors. (CD4+) T-cells is responsible for pro-inflammatory cytokines production and subsequent joint destruction .
The aetiology of RA-ILD may be related to smoking and other factors that activate autoimmunity and the attack of post-transcriptionally modified self-proteins, such as citrullinated peptides. Citrullinated peptide can be produced in the lungs of some patients, causing a pulmonary fibrosis .
Major subtypes of RA-ILD are defined by their histopathological or (HRCT) patterns
. Programmed death-1 belongs to CD28/B7 family and is expressed on the surface of activated T cells, B cells, NK cells, dendritic cells and Treg cells. sPD-1 is the soluble form of PD-1 that is obtained by phosphoric acid hydrolysis of membrane type PD-1 .
Programmed death-1 and its ligands are important negative regulators of the immune system. .
In RA, Persistent synovial T cell activation and inflammation may be reasoned to positive regulators overexpression, aberrant expression of negative regulators or functional antagonism of these molecules by soluble factors .
sPD-1 inhibits the PD-1/PD-L signalling pathway by interacting with PD-Ls and promotes the T cell activation .
- Conditions
- Rheumatoid Arthritis
- Being tested
- soluble programmed death 1biomarker
- Keywords
- Interstitial lung disease
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soluble programmed death 1biomarkerDiagnostic test
soluble programmed death 1biomarker
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the levels of serum (sPD1)by ELISA in RA patients
Evaluate the levels of serum (sPD1) in RA patients and its correlation with ILD
Measured: baseline
Secondary outcomes (1)
early diagnosis of ILD in patients with RA
Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Omar Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105230
- Sponsor's protocol ID
- sPD1 in RA
- Status last verified
- Jan 2022
- First submitted
- 7 Oct 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Programmed Death 1 (sPD1) is a Diagnostic Biomarker of ILD in Patients With Rheumatoid Arthritis Disease
- ClinicalTrials.gov ID
- NCT05105230
- Acronym / sponsor ID
- sPD1 in RA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Interstitial lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 3 Nov 2021 (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.
- Evaluate the levels of serum (sPD1) in RA patients with ILD and those without.
- Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation of RA
Detailed description
Rheumatoid arthritis is a chronic autoimmune disease that is characterized by a systemic inflammatory state that affects joints and other organs .
There are many types of RA-related pulmonary diseases. RA-related pulmonary diseases include airway disease such as bronchiolitis. There are interstitial lung diseases that include non-specific interstitial pneumonitis and usual interstitial pneumonia .
The pathogenesis of RA is multifactorial with contributions from genetic and environmental factors. (CD4+) T-cells is responsible for pro-inflammatory cytokines production and subsequent joint destruction .
The aetiology of RA-ILD may be related to smoking and other factors that activate autoimmunity and the attack of post-transcriptionally modified self-proteins, such as citrullinated peptides. Citrullinated peptide can be produced in the lungs of some patients, causing a pulmonary fibrosis .
Major subtypes of RA-ILD are defined by their histopathological or (HRCT) patterns
. Programmed death-1 belongs to CD28/B7 family and is expressed on the surface of activated T cells, B cells, NK cells, dendritic cells and Treg cells. sPD-1 is the soluble form of PD-1 that is obtained by phosphoric acid hydrolysis of membrane type PD-1 .
Programmed death-1 and its ligands are important negative regulators of the immune system. .
In RA, Persistent synovial T cell activation and inflammation may be reasoned to positive regulators overexpression, aberrant expression of negative regulators or functional antagonism of these molecules by soluble factors .
sPD-1 inhibits the PD-1/PD-L signalling pathway by interacting with PD-Ls and promotes the T cell activation .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Adult RA Patients 2. Adult RA patients with ILD 3. Adult healthy control
Key inclusion criteria (2 listed)
- Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA (7).
- Adult RA patients with ILD (Nonspecific idiopathic interstitial pneumonia more than 16 years old).
Key exclusion criteria (7 listed)
- Patients with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa sarcoidosis, dermatomyositis, scleroderma, spondylarthritis and inflammatory bowel disease).
- RA patients with lung affection other than ILD
- Patients with malignant tumors
- Patients with active infection
- Patients with severe heart, lung, and kidney dysfunction
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 |
|---|---|---|
| soluble programmed death 1biomarkersoluble programmed death 1biomarker | Diagnostic test | – |
Primary outcome
measure the levels of serum (sPD1)by ELISA in RA patients
Time frame: baseline
Evaluate the levels of serum (sPD1) in RA patients and its correlation with ILD
1 secondary outcome
early diagnosis of ILD in patients with RA
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Soluble Programmed Death Molecule 1 (sPD-1) As Predictor of Interstitial Lung Disease in Rheumatoid ArthritisLink provided by the sponsor.
- The PD-1/PD-L pathway in rheumatic diseasesLink provided by the sponsor.
- Clinical significance of soluble programmed death-1(sPD-1) in rheumatoid arthritis patients: Relation to disease activity and functional statusLink provided by the sponsor.
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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?
An observational study of 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 7 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 12 Jan 2022. 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 Salwa omar (01206889948, salwa8774@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the levels of serum (sPD1)by ELISA in RA patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.