Rheumatoid Arthritis (RA)NCT07069088
This Study Aims to Characterize and Compare Patients of Adult-onset RA With Patients of Elderly-onset RA Based on the Clinical Manifestations, Disease Activity, Severity Parameters, and Therapeutic Features
An observational study of Rheumatoid Arthritis (RA), run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to characterize and compare patients of adult-onset RA with patients of elderly-onset RA based on the clinical manifestations, disease activity, severity parameters, and therapeutic features. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Mar 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Rheumatoid Arthritis patients
Who may be able to join
- 1) Patients fulfill the 2010 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis [7] 2) Age of disease onset above 16 years old. 3) patient is cooperative and can answer questions. 4) Patients who are able and willing to give written informed consent.
Who cannot join
- 1) Other rheumatologic or collagen diseases. 2) Age below 16 years. 3) Active infection 4) Pregnancy 5) Malignancy 6) Uncooperative patients. 7) Patient not able and willing to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Rheumatology and Rehabilitation department at Sohag University Hospital
Sohag
About this study
Official title: Clinical Characteristics of Elderly-Onset Versus Adult-Onset Rheumatoid Arthritis; a Cross-Sectional Study
This study aims to characterize and compare patients of adult-onset RA with patients of elderly-onset RA based on the clinical manifestations, disease activity, severity parameters, and therapeutic features.
- Conditions
- Rheumatoid Arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
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 |
|---|---|---|
| Adult- onset RA group I (16-40 years) | 16-40 years | |
| Adult- onset RA group II (41-60 years) | 41-60 years | |
| EORA >60 years | >60 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity assessment
Disease activity assessment using DAS 28 Quality of life: HAQ (health assessment questionnaire
Measured: from enrollment time to the end of examination and investigation at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (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 only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Abdelrazik, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069088
- Sponsor's protocol ID
- Soh-Med--25-6-5MS
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patients will be subjected to the following: 1. Full medical history from the patients, including Demographic data (Age, Sex, Marital status, Occupation, Residence), duration of disease, Comorbidities, and the treatments that patients receive. 2. Full clinical examination and assessment including: 1. General examination and Complete rheumatological examination. 2. Application of American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis, on all RA patients. 3. Laboratory investigations: (Blood sample will be collected into 5ml tubes containing Ethylenediaminetetraacetic acid (EDTA) ). * complete blood count (CBC) (done on fully automatic BC 21S hematology analyzer). * erythrocyte sedimentation rate (ESR). * C- reactive protein (CRP) (using Enzyme-linked immunosorbent assay (ELISA)). * rheumatoid factor (RF) (using ELISA). * anti-cyclic citrullinated peptide antibody (ACCP Ab) (using ELISA). 4. Disease activity assessm
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Elderly-Onset Versus Adult-Onset Rheumatoid Arthritis; a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07069088
- Acronym / sponsor ID
- Soh-Med--25-6-5MS
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 16 Jul 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.
This study aims to characterize and compare patients of adult-onset RA with patients of elderly-onset RA based on the clinical manifestations, disease activity, severity parameters, and therapeutic features.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult- onset RA group I (16-40 years) | – | –16-40 years |
| Adult- onset RA group II (41-60 years) | – | –41-60 years |
| EORA >60 years | – | –>60 years |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rheumatoid Arthritis patients
Key inclusion criteria (1 listed)
- 1) Patients fulfill the 2010 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis [7] 2) Age of disease onset above 16 years old. 3) patient is cooperative and can answer questions. 4) Patients who are able and willing to give written informed consent.
Key exclusion criteria (1 listed)
- 1) Other rheumatologic or collagen diseases. 2) Age below 16 years. 3) Active infection 4) Pregnancy 5) Malignancy 6) Uncooperative patients. 7) Patient not able and willing to give written informed consent.
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
Disease activity assessment
Time frame: from enrollment time to the end of examination and investigation at 4 weeks
Disease activity assessment using DAS 28 Quality of life: HAQ (health assessment questionnaire
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 16 Jul 2025.
- 1\. Elderly-onset rheumatoid arthritisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All patients will be subjected to the following: 1. Full medical history from the patients, including Demographic data (Age, Sex, Marital status, Occupation, Residence), duration of disease, Comorbidities, and the treatments that patients receive. 2. Full clinical examination and assessment including: 1. General examination and Complete rheumatological examination. 2. Application of American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis, on all RA patients. 3. Laboratory investigations: (Blood sample will be collected into 5ml tubes containing Ethylenediaminetetraacetic acid (EDTA) ). * complete blood count (CBC) (done on fully automatic BC 21S hematology analyzer). * erythrocyte sedimentation rate (ESR). * C- reactive protein (CRP) (using Enzyme-linked immunosorbent assay (ELISA)). * rheumatoid factor (RF) (using ELISA). * anti-cyclic citrullinated peptide antibody (ACCP Ab) (using ELISA). 4. Disease activity assessm
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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.
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), 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. 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?
Disease activity assessment (time frame: from enrollment time to the end of examination and investigation at 4 weeks). 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 16 Jul 2025.