OsteoarthritisHPGD-OA-AS-USNCT07751263
15-Hydroxyprostaglandin Dehydrogenase in Osteoarthritis and Ankylosing Spondylitis
An observational study of Osteoarthritis and Ankylosing Spondylitis, run by Assiut University.
Trial summary
To evaluate serum and synovial fluid 15-PGDH levels in patients with osteoarthritis and ankylosing spondylitis and determine their associations with clinical and musculoskeletal ultrasound features. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Ankylosing Spondylitis
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2026to 2 Aug 2028
- How long will I take part?
- 1 Year
- 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: Will be recruited from Rheumatology, Rehabilitation and Physical Medicine department- Assuit university hospital. Written informed consent will be obtained from all participants. Patients include: * Patients with osteoarthritis. * Patients with AS * Age- and sex-matched healthy controls.
Who may be able to join
- Adults aged 18 years or older. AxSpA group Patients diagnosed as ankylosing spondylitis according to ASAS criteria . R OA group
- Adults with osteoarthritis Diagnosed according to the American College of Rheumatology classification criteria.[8]R ACR Clinical classification criteria for Osteoarthritis of the hip ACR Clinical classification criteria for Osteoarthritis of the knee ACR Clinical classification criteria for Osteoarthritis of the hand Control group Age- and sex-matched healthy controls.
Who cannot join
- • Other inflammatory arthritides such as psoriatic arthritis, gout, or SLE-related arthritis.
- Septic arthritis or suspected joint infection.
- Recent intra-articular steroid injection if it may influence biomarker results.
- Any major systemic illness likely to affect biomarker measurement or ultrasound interpretation.
- Patients received certain drugs as non-steroidal anti-inflammatory drugs (NSAIDs)
About this study
Official title: 15-Hydroxyprostaglandin Dehydrogenase in Osteoarthritis and Ankylosing Spondylitis: Associations With Clinical and Musculoskeletal Ultrasound Features.
To evaluate serum and synovial fluid 15-PGDH levels in patients with osteoarthritis and ankylosing spondylitis and determine their associations with clinical and musculoskeletal ultrasound features.
To compare 15-PGDH concentrations among patients with knee osteoarthritis, and ankylosing spondylitis with knee effusion
To evaluate whether serum 15-PGDH reflects intra-articular 15-PGDH concentrations.
Analysis the level of 15-PGDH in relation to disease activity and severity of both diseases.
Read the detailed description
Osteoarthritis (OA) and Ankylosing Spondylitis (AS) are chronic musculoskeletal disorders with different pathophysiology, clinical manifestations, and management strategies. OA is a degenerative joint disease in which inflammation also contributes to symptom severity and structural progression, while AS is a chronic inflammatory spondyloarthropathy characterized by axial inflammation and, in some patients, peripheral arthritis.
Prostaglandin E2 (PGE2) is a key mediator involved in pain, inflammation, and tissue remodeling in musculoskeletal disease. 15-hydroxyprostaglandin dehydrogenase (15-PGDH) is the major enzyme responsible for degradation of prostaglandins, especially PGE2, and therefore acts as an important regulator of prostaglandin activity in the joint microenvironment. In inflammatory arthritis, synovial studies have shown that 15-PGDH is present in healthy and inflamed synovial tissue, mainly in lining macrophages, fibroblasts, and vessels, supporting a possible role in local inflammatory regulation.
In osteoarthritis, experimental evidence indicates that 15-PGDH is biologically relevant to cartilage degeneration and repair, and inhibition of 15-PGDH may promote cartilage regeneration and reduce OA-associated pain. These findings support the rationale for investigating 15-PGDH as a biomarker in OA and AS.
Musculoskeletal ultrasound is a valuable non-invasive imaging tool in rheumatology and can detect synovial hypertrophy, effusion, and power Doppler activity. EULAR has published recommendations for standardized ultrasound procedures and reporting in rheumatic and musculoskeletal diseases, supporting its use in this study.
Accordingly, this study will assess serum and synovial fluid 15-PGDH levels in patients with OA and AS and examine their correlation with clinical and musculoskeletal ultrasound features.
- Conditions
- Osteoarthritis, Ankylosing Spondylitis
- Medical subject headings
- Osteoarthritis, Spondylitis, Ankylosing
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 |
|---|---|---|
| • Arm 1: Osteoarthritis • Arm 2: Ankylosing spondylitis • Arm 3: Healthy controls | Three analytical study arms: OA, AS, and control groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 15-hydroxyprostaglandin dehydrogenase (15-PGDH) levelr
To assess the relationship between 15-PGDH and clinical and musculoskeletal ultrasound parameters in osteoarthritis and ankylosing spondylitis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start2 Aug 2026 (estimated)
- Primary completion2 Aug 2027 (estimated)
- Study completion2 Aug 2028 (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 OsteoarthritisStudies 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
- Prospective
- Enrolment
- 51 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Allah Nashaat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751263
- Sponsor's protocol ID
- OA-AS-15 PGDH
- Acronym
- HPGD-OA-AS-US
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gheorghe KR, Sadique S, Leclerc P, Idborg H, Wobst I, Catrina AI, Jakobsson PJ, Korotkova M. Limited effect of anti-rheumatic treatment on 15-prostaglandin dehydrogenase in rheumatoid arthritis synovial tissue. Arthritis Res Ther. 2012 May 22;14(3):R121. doi: 10.1186/ar3851.
PubMed 22616846Kim HJ, Lee S, Lee HY, Won H, Chang SH, Nah SS. 15-hydroxyprostaglandin dehydrogenase is upregulated by hydroxychloroquine in rheumatoid arthritis fibroblast-like synoviocytes. Mol Med Rep. 2015 Sep;12(3):4141-4148. doi: 10.3892/mmr.2015.3931. Epub 2015 Jun 15.
PubMed 26082314Capkin E. Musculoskeletal ultrasonography in rheumatic diseases. Turk J Med Sci. 2023 Jul 20;53(6):1537-1551. doi: 10.55730/1300-0144.5723. eCollection 2023.
PubMed 38813491
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 15-Hydroxyprostaglandin Dehydrogenase in Osteoarthritis and Ankylosing Spondylitis: Associations With Clinical and Musculoskeletal Ultrasound Features.
- ClinicalTrials.gov ID
- NCT07751263
- Acronym / sponsor ID
- HPGD-OA-AS-US / OA-AS-15 PGDH
- Conditions
- Osteoarthritis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Aug 2026 (estimated)
- Primary completion
- 2 Aug 2027 (estimated)
- Study completion
- 2 Aug 2028 (estimated)
- First posted
- 7 Aug 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.
To evaluate serum and synovial fluid 15-PGDH levels in patients with osteoarthritis and ankylosing spondylitis and determine their associations with clinical and musculoskeletal ultrasound features.
To compare 15-PGDH concentrations among patients with knee osteoarthritis, and ankylosing spondylitis with knee effusion
To evaluate whether serum 15-PGDH reflects intra-articular 15-PGDH concentrations.
Analysis the level of 15-PGDH in relation to disease activity and severity of both diseases.
Detailed description
Osteoarthritis (OA) and Ankylosing Spondylitis (AS) are chronic musculoskeletal disorders with different pathophysiology, clinical manifestations, and management strategies. OA is a degenerative joint disease in which inflammation also contributes to symptom severity and structural progression, while AS is a chronic inflammatory spondyloarthropathy characterized by axial inflammation and, in some patients, peripheral arthritis.
Prostaglandin E2 (PGE2) is a key mediator involved in pain, inflammation, and tissue remodeling in musculoskeletal disease. 15-hydroxyprostaglandin dehydrogenase (15-PGDH) is the major enzyme responsible for degradation of prostaglandins, especially PGE2, and therefore acts as an important regulator of prostaglandin activity in the joint microenvironment. In inflammatory arthritis, synovial studies have shown that 15-PGDH is present in healthy and inflamed synovial tissue, mainly in lining macrophages, fibroblasts, and vessels, supporting a possible role in local inflammatory regulation.
In osteoarthritis, experimental evidence indicates that 15-PGDH is biologically relevant to cartilage degeneration and repair, and inhibition of 15-PGDH may promote cartilage regeneration and reduce OA-associated pain. These findings support the rationale for investigating 15-PGDH as a biomarker in OA and AS.
Musculoskeletal ultrasound is a valuable non-invasive imaging tool in rheumatology and can detect synovial hypertrophy, effusion, and power Doppler activity. EULAR has published recommendations for standardized ultrasound procedures and reporting in rheumatic and musculoskeletal diseases, supporting its use in this study.
Accordingly, this study will assess serum and synovial fluid 15-PGDH levels in patients with OA and AS and examine their correlation with clinical and musculoskeletal ultrasound features.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Arm 1: Osteoarthritis • Arm 2: Ankylosing spondylitis • Arm 3: Healthy controls | – | –Three analytical study arms: OA, AS, and control groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Will be recruited from Rheumatology, Rehabilitation and Physical Medicine department- Assuit university hospital. Written informed consent will be obtained from all participants. Patients include: * Patients with osteoarthritis. * Patients with AS * Age- and sex-matched healthy controls.
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
- • Other inflammatory arthritides such as psoriatic arthritis, gout, or SLE-related arthritis.
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 15-hydroxyprostaglandin dehydrogenase (15-PGDH) levelr
Time frame: 2 years
To assess the relationship between 15-PGDH and clinical and musculoskeletal ultrasound parameters in osteoarthritis and ankylosing spondylitis.
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 7 Aug 2026.
- Background: PubMed 22616846Gheorghe KR, Sadique S, Leclerc P, Idborg H, Wobst I, Catrina AI, Jakobsson PJ, Korotkova M. Limited effect of anti-rheumatic treatment on 15-prostaglandin dehydrogenase in rheumatoid arthritis synovial tissue. Arthritis Res Ther. 2012 May 22;14(3):R121. doi: 10.1186/ar3851.
- Background: PubMed 26082314Kim HJ, Lee S, Lee HY, Won H, Chang SH, Nah SS. 15-hydroxyprostaglandin dehydrogenase is upregulated by hydroxychloroquine in rheumatoid arthritis fibroblast-like synoviocytes. Mol Med Rep. 2015 Sep;12(3):4141-4148. doi: 10.3892/mmr.2015.3931. Epub 2015 Jun 15.
- Background: PubMed 38813491Capkin E. Musculoskeletal ultrasonography in rheumatic diseases. Turk J Med Sci. 2023 Jul 20;53(6):1537-1551. doi: 10.55730/1300-0144.5723. eCollection 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Ankylosing Spondylitis, 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 7 Aug 2026. 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?
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 15-hydroxyprostaglandin dehydrogenase (15-PGDH) levelr (time frame: 2 years). 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 NCT07751263, 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 7 Aug 2026.