Rheumatoid Arthritis (RA)FAPNCT07393217
Correlation Between Circulating Fibroblast Activation Protein (FAP) and Fibrosis in Two Diseases (Rheumatoid Arthritis and Systemic Sclerosis)
An observational study of Rheumatoid Arthritis (RA) and Systemic Sclerosis (SSc), run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to measure a blood protein called fibroblast activation protein (FAP), which is linked to tissue scarring and inflammation. A small blood sample will be taken from participants (RA , SSc patients and healthy people ), and the FAP level will be measured and compared with routine clinical examinations… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc)
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include adult patients diagnosed with rheumatoid arthritis (RA) or systemic sclerosis (SSc). Participants will be recruited consecutively from the Rheumatology and Rehabilitation outpatient clinics and inpatient units of the study center. The sample will consist of three parallel groups: Patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR classification criteria. Patients with systemic sclerosis diagnosed according to the 2013 ACR/EULAR classification criteria. Healthy population who don't have any autoimmune disease.
Who may be able to join
- Age ≥18 years. Confirmed diagnosis of RA (ACR/EULAR) or SSc (ACR/EULAR).
- Ability and willingness to provide informed consent. Cooperative patient able to answer questions.
Who cannot join
- Patients under 18 years' old
- Active cancer or history of cancer within 5 years.
- Other major fibrotic systemic disease that could confound circulating FAP levels.
- Acute infection at time of sampling.
- Pregnancy or breastfeeding.
- Other autoimmune diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Circulating Fibroblast Activation Protein (FAP) As A Marker for Fibroblast-Driven Pathology in Rheumatoid Arthritis and Systemic Sclerosis : Implication for Joint, Skin and Lung Fibrosis
This study aims to measure a blood protein called fibroblast activation protein (FAP), which is linked to tissue scarring and inflammation. A small blood sample will be taken from participants (RA , SSc patients and healthy people ), and the FAP level will be measured and compared with routine clinical examinations, imaging studies, and lung function tests.
The purpose of this study is to improve understanding of disease activity and lung involvement in these conditions and to explore whether FAP could be useful as a blood marker for future patients. Participation in this study will not change the participant's usual medical care.
- Keywords
- Fibroblast Activation protein, Rheumatoid Arthritis, systemic sclerosis, lung fibrosis, skin fibrosis
- Medical subject headings
- Arthritis, Rheumatoid, Scleroderma, Systemic, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis patients | Not described | |
| systemic sclerosis patients | Not described | |
| control healthy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum fibroblast activation protein (FAP) concentration measured by ELISA in patients with rheumatoid arthritis and systemic sclerosis
Measured: At baseline (Day 1)
Secondary outcomes (2)
disease activity
Correlation between serum FAP concentration and disease activity score in rheumatoid arthritis and systemic sclerosis
Measured: baseline
pulmonary involvement
Correlation between serum FAP concentration and pulmonary involvement in patients with rheumatoid arthritis and systemic sclerosis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toqa Mahfouz Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393217
- Sponsor's protocol ID
- Soh-Med--25-12-9MD
- Acronym
- FAP
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Fibroblast Activation Protein (FAP) As A Marker for Fibroblast-Driven Pathology in Rheumatoid Arthritis and Systemic Sclerosis : Implication for Joint, Skin and Lung Fibrosis
- ClinicalTrials.gov ID
- NCT07393217
- Acronym / sponsor ID
- FAP / Soh-Med--25-12-9MD
- Keywords
- Fibroblast Activation protein, Rheumatoid Arthritis, systemic sclerosis, lung fibrosis, skin fibrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
This study aims to measure a blood protein called fibroblast activation protein (FAP), which is linked to tissue scarring and inflammation. A small blood sample will be taken from participants (RA , SSc patients and healthy people ), and the FAP level will be measured and compared with routine clinical examinations, imaging studies, and lung function tests.
The purpose of this study is to improve understanding of disease activity and lung involvement in these conditions and to explore whether FAP could be useful as a blood marker for future patients. Participation in this study will not change the participant's usual medical care.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients | – | – |
| systemic sclerosis patients | – | – |
| control healthy group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients diagnosed with rheumatoid arthritis (RA) or systemic sclerosis (SSc). Participants will be recruited consecutively from the Rheumatology and Rehabilitation outpatient clinics and inpatient units of the study center. The sample will consist of three parallel groups: Patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR classification criteria. Patients with systemic sclerosis diagnosed according to the 2013 ACR/EULAR classification criteria. Healthy population who don't have any autoimmune disease.
Key inclusion criteria (2 listed)
- Age ≥18 years. Confirmed diagnosis of RA (ACR/EULAR) or SSc (ACR/EULAR).
- Ability and willingness to provide informed consent. Cooperative patient able to answer questions.
Key exclusion criteria (6 listed)
- Patients under 18 years' old
- Active cancer or history of cancer within 5 years.
- Other major fibrotic systemic disease that could confound circulating FAP levels.
- Acute infection at time of sampling.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum fibroblast activation protein (FAP) concentration measured by ELISA in patients with rheumatoid arthritis and systemic sclerosis
Time frame: At baseline (Day 1)
2 secondary outcomes
disease activity
Time frame: baseline
pulmonary involvement
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA) and Systemic Sclerosis (SSc), run by Sohag University at 1 site in Egypt.
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 6 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum fibroblast activation protein (FAP) concentration measured by ELISA in patients with rheumatoid arthritis and systemic sclerosis (time frame: At baseline (Day 1)). 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 6 Feb 2026.