Rheumatoid ArthritisNCT06562049
Carpal Bone Erosion in Rheumatoid Arthritis :Diagnostic Value
An observational study of Rheumatoid Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- musculoskeletal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 1 Oct 2025
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8] 2. SLE patients fulfilled the 2019 ACR\EULAR classification criteria for SLE.[9] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent
Who may be able to join
- 1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8] 2. SLE patients fulfilled the 2019 ACR\EULAR classification criteria for SLE.[9] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent.
Who cannot join
- 1. Age below 18 years and above 60 years. 2. Uncooperative patients. 3. Patient not able and willing to give written informed consent.
Trial locations and contacts
1 site in 1 country.
ahmed M mahrous, Professor contact
About this study
Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other areas under influence of RA. Changes happen to be symmetrical and may present as fusiform soft tissue swelling, regional osteoporosis, marginal-central erosions, cartilage damage, joint destruction, narrowing of joint space and fibrous ankyloses. Wrist, metacarpophalangeal and metatarsophalangeal joints are the first sites to be affected .Over the past few years, an increasing number of rheumatologists have started to use US in the clinical setting of the early arthritis clinic. While US allows for an accurate and non-invasive multisite assessment of joint involvement in patients with RA, time for US examination is not infinite
- Conditions
- Rheumatoid Arthritis
- Being tested
- musculoskeletal ultrasound
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musculoskeletal ultrasoundRadiation
musculoskeletal ultrasound on both hands
| Study group | Role | What they receive |
|---|---|---|
| cases | rheumatoid arthriris patients Receives: Radiation: musculoskeletal ultrasound | |
| control | systemic lupus patients Receives: Radiation: musculoskeletal ultrasound | |
| controls | healthy controls Receives: Radiation: musculoskeletal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone erosion
erosions in carpal bones and MCP 2,5 in both hands
Measured: max 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abdelaal Aly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562049
- Sponsor's protocol ID
- soh-med-24-07-10MS
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sommer OJ, Kladosek A, Weiler V, Czembirek H, Boeck M, Stiskal M. Rheumatoid arthritis: a practical guide to state-of-the-art imaging, image interpretation, and clinical implications. Radiographics. 2005 Mar-Apr;25(2):381-98. doi: 10.1148/rg.252045111.
PubMed 15798057Ejbjerg BJ, Vestergaard A, Jacobsen S, Thomsen H, Ostergaard M. Conventional radiography requires a MRI-estimated bone volume loss of 20% to 30% to allow certain detection of bone erosions in rheumatoid arthritis metacarpophalangeal joints. Arthritis Res Ther. 2006;8(3):R59. doi: 10.1186/ar1919. Epub 2006 Mar 15.
PubMed 16542505Mottonen TT. Prediction of erosiveness and rate of development of new erosions in early rheumatoid arthritis. Ann Rheum Dis. 1988 Aug;47(8):648-53. doi: 10.1136/ard.47.8.648.
PubMed 3137902
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Bone Erosion in Rheumatoid Arthritis :Diagnostic Value
- ClinicalTrials.gov ID
- NCT06562049
- Acronym / sponsor ID
- soh-med-24-07-10MS
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Aug 2024 (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 systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other areas under influence of RA. Changes happen to be symmetrical and may present as fusiform soft tissue swelling, regional osteoporosis, marginal-central erosions, cartilage damage, joint destruction, narrowing of joint space and fibrous ankyloses. Wrist, metacarpophalangeal and metatarsophalangeal joints are the first sites to be affected .Over the past few years, an increasing number of rheumatologists have started to use US in the clinical setting of the early arthritis clinic. While US allows for an accurate and non-invasive multisite assessment of joint involvement in patients with RA, time for US examination is not infinite
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cases | – | Radiation: musculoskeletal ultrasoundrheumatoid arthriris patients |
| control | – | Radiation: musculoskeletal ultrasoundsystemic lupus patients |
| controls | – | Radiation: musculoskeletal ultrasoundhealthy controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8] 2. SLE patients fulfilled the 2019 ACR\EULAR classification criteria for SLE.[9] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent
Key inclusion criteria (1 listed)
- 1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8] 2. SLE patients fulfilled the 2019 ACR\EULAR classification criteria for SLE.[9] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent.
Key exclusion criteria (1 listed)
- 1. Age below 18 years and above 60 years. 2. Uncooperative patients. 3. 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musculoskeletal ultrasoundmusculoskeletal ultrasound on both hands | Radiation | cases, control, controls |
Primary outcome
bone erosion
Time frame: max 1 year
erosions in carpal bones and MCP 2,5 in both hands
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 15798057Sommer OJ, Kladosek A, Weiler V, Czembirek H, Boeck M, Stiskal M. Rheumatoid arthritis: a practical guide to state-of-the-art imaging, image interpretation, and clinical implications. Radiographics. 2005 Mar-Apr;25(2):381-98. doi: 10.1148/rg.252045111.
- Background: PubMed 16542505Ejbjerg BJ, Vestergaard A, Jacobsen S, Thomsen H, Ostergaard M. Conventional radiography requires a MRI-estimated bone volume loss of 20% to 30% to allow certain detection of bone erosions in rheumatoid arthritis metacarpophalangeal joints. Arthritis Res Ther. 2006;8(3):R59. doi: 10.1186/ar1919. Epub 2006 Mar 15.
- Background: PubMed 3137902Mottonen TT. Prediction of erosiveness and rate of development of new erosions in early rheumatoid arthritis. Ann Rheum Dis. 1988 Aug;47(8):648-53. doi: 10.1136/ard.47.8.648.
- 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. This study is not recruiting at the moment.
ahmed M mahrous, Professor contact
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, 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abeer A abdelaal, Resident (01206290115, abeer_abdelaal_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone erosion (time frame: max 1 year). 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 NCT06562049, which also lists 3 linked publications.
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 20 Aug 2024.