Rheumatoid ArthritisNCT07272850
Comparison Between JAK Inhibitors and Traditional Treatment of Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Arthritis, run by Assiut University.
Trial summary
Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects about 1% of the world's population [1]. The disease is characterized by synovial membrane inflammation. The impact of RA on quality of life is significant, as it can lead to considerable disability, reduced mobility, and an increased risk of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, Arthritis
- What is being tested?
- JAK inhibitors and traditional treatment of rheumatoid arthritis
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 20 Oct 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving traditional treatement
Who may be able to join
- • RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA.
- Age; 18-60
Who cannot join
- • the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis),
- history of active infections, malignancy, or chronic diseases affecting hematological
- parameters (e.g., anemia unrelated to RA, chronic kidney disease)
- RA patients in remission
- pregnant and lactating female patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Haematological Parameters and Musculoskeletal Ultrasound Findings of Rheumatoid Arthritis Patients Recieving JAK Inhibitors Versus Traditional Treatment
Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects about 1% of the world's population [1]. The disease is characterized by synovial membrane inflammation. The impact of RA on quality of life is significant, as it can lead to considerable disability, reduced mobility, and an increased risk of additional health complications [2].
CsDMARDs are the first-line drugs for RA treatment, of which methotrexate (MTX) is the cornerstone drug and monotherapy is recommended as the first choice (3).
However, previous studies had shown that 50% of RA patients had poor treatment effect on methotrexate or inadequate response to re-medication after relapse, resulting in drug resistance (4), resulting in no significant relief of symptoms and still high disease activity. EULAR had indicated that interleukin-6 (IL-6) receptor inhibitors and JAK inhibitors may have advantages over other biological disease-modifying anti-rheumatic drugs (bDMARDs) in patients who were not suitable for csDMARDs (5) Therefore, JAK inhibitors is used as monotherapy or combination therapy, which would provide a new strategy for clinical treatment. A few researches evaluated the relationship between PLT, RBC, Hb, red blood cells-platelet ratio (RPR), and the hemoglobin-platelet ratio (HPR) and RA disease activity. There is growing evidence that metrics like RDW and MPV, as well as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and others have been considered to be accurate, reliable inflammatory biomarkers in autoimmune illnesses[6,7] US has proven itself to be a useful imaging method for assessing articular and periarticular inflammation in small and large joints throughout the last years High resolution musculoskeletal ultrasound (MSUS), incorporating power Doppler ultrasound (PDUS), has demonstrated to be significantly more accurate than clinical evaluation in visualizing the inflammatory process. Furthermore, relatively few studies have examined ankle joint involvement in individuals with RA who lack symptoms [8].
- Conditions
- Rheumatoid Arthritis, Arthritis
- Being tested
- JAK inhibitors and traditional treatment of rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAK inhibitors and traditional treatment of rheumatoid arthritisDrug
Type of the study:
- cross sectional study
- two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving traditional treatement
2.4. 2- Study Setting: Internal medicine department ,out patient rheumatology clinics of assuit university hospitals 2.4.3- study duration : October 2025 to October 2026
2.4. 4- Study subjects:
- Inclusion criteria:
- RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA.
- Age; 18-60
- Exclusion criteria:
- the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis),
- history of active infections, malignancy, or chronic diseases affecting hematological
- parameters (e.g., anemia unrelated to RA, chronic kidney disease)
- RA patients in remission
- pregnant and lactating female patients
- Sample Size Calculation Based on determining the main outcome variable, the estimated
| Study group | Role | What they receive |
|---|---|---|
| Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving tra | Not described Receives: Drug: JAK inhibitors and traditional treatment of rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in hematological parameters as MLR
MLR were determined by dividing the abso- lute neutrophil count by the absolute lymphocyte count, the absolute platelet count by the absolute lymphocyte count, and the absolute monocyte count by the absolute lymphocyte count, respec- tively
Measured: 1 year
improvement in musculoskeletal ultrasound scores.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Oct 2026 (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 only
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gamal Mohamed Abd Elaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272850
- Sponsor's protocol ID
- JAK inhibitors in RA
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Haematological Parameters and Musculoskeletal Ultrasound Findings of Rheumatoid Arthritis Patients Recieving JAK Inhibitors Versus Traditional Treatment
- ClinicalTrials.gov ID
- NCT07272850
- Acronym / sponsor ID
- JAK inhibitors in RA
- Conditions
- Rheumatoid Arthritis, Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 9 Dec 2025 (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 (RA) is a chronic autoimmune disease that affects about 1% of the world's population [1]. The disease is characterized by synovial membrane inflammation. The impact of RA on quality of life is significant, as it can lead to considerable disability, reduced mobility, and an increased risk of additional health complications [2].
CsDMARDs are the first-line drugs for RA treatment, of which methotrexate (MTX) is the cornerstone drug and monotherapy is recommended as the first choice (3).
However, previous studies had shown that 50% of RA patients had poor treatment effect on methotrexate or inadequate response to re-medication after relapse, resulting in drug resistance (4), resulting in no significant relief of symptoms and still high disease activity. EULAR had indicated that interleukin-6 (IL-6) receptor inhibitors and JAK inhibitors may have advantages over other biological disease-modifying anti-rheumatic drugs (bDMARDs) in patients who were not suitable for csDMARDs (5) Therefore, JAK inhibitors is used as monotherapy or combination therapy, which would provide a new strategy for clinical treatment. A few researches evaluated the relationship between PLT, RBC, Hb, red blood cells-platelet ratio (RPR), and the hemoglobin-platelet ratio (HPR) and RA disease activity. There is growing evidence that metrics like RDW and MPV, as well as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and others have been considered to be accurate, reliable inflammatory biomarkers in autoimmune illnesses[6,7] US has proven itself to be a useful imaging method for assessing articular and periarticular inflammation in small and large joints throughout the last years High resolution musculoskeletal ultrasound (MSUS), incorporating power Doppler ultrasound (PDUS), has demonstrated to be significantly more accurate than clinical evaluation in visualizing the inflammatory process. Furthermore, relatively few studies have examined ankle joint involvement in individuals with RA who lack symptoms [8].
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving tra | – | Drug: JAK inhibitors and traditional treatment of rheumatoid arthritis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving traditional treatement
Key inclusion criteria (2 listed)
- • RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA.
Key exclusion criteria (5 listed)
- • the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis),
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 |
|---|---|---|
| JAK inhibitors and traditional treatment of rheumatoid arthritisType of the study: * cross sectional study * two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving traditional treatement 2.4. 2- Study Setting: Internal medicine department ,out patient rheumatology clinics of assuit university hospitals 2.4.3- study duration : October 2025 to October 2026 2.4. 4- Study subjects: 1. Inclusion criteria: * RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA. * Age; 18-60 2. Exclusion criteria: * the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis), * history of active infections, malignancy, or chronic diseases affecting hematological * parameters (e.g., anemia unrelated to RA, chronic kidney disease) * RA patients in remission * pregnant and lactating female patients 3. Sample Size Calculation Based on determining the main outcome variable, the estimated | Drug | Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving tra |
Primary outcome
changes in hematological parameters as MLR
Time frame: 1 year
MLR were determined by dividing the abso- lute neutrophil count by the absolute lymphocyte count, the absolute platelet count by the absolute lymphocyte count, and the absolute monocyte count by the absolute lymphocyte count, respec- tively
improvement in musculoskeletal ultrasound scores.
Time frame: 1 year
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 9 Dec 2025.
- Related InfoLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and 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 5 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 9 Dec 2025. 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?
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?
Contact Asmaa Gamal mohamed, Master of Clinical Hematology (+2 01091076754, asmaagamak2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in hematological parameters as MLR (time frame: 1 year). The study lists 2 primary outcomes in all. 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 9 Dec 2025.