Rheumatoid Arthritis (RA) and Osteoarthritis (OA)NCT04474912
Serum IL-17 Correlated With Inflammatory Changes in Osteoarthritis and Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA) and Osteoarthritis (OA), run by Zagazig University at 1 site in Egypt.
Trial summary
The total number of the included subjects was 120 in 3 equal groups (RA, OA and control). All subject was subjected to serum IL17 level measurement. MSK US (of both wrists, MCPs, PIPs and DIPs) was done to all patients in RA and OA groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 29 Nov 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study participants will be recruited from attendants to Rheumatology and Rehabilitation outpatient clinic at Zagazig University Hospitals
Who may be able to join
- A patient is considered having definite RA if he/she scores at least 6 points in the established classification system
- A patient is considered having Hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands
Who cannot join
- Any subject with liver diseases, coronary artery diseases, kidney diseases or other inflammatory conditions was excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
Official title: Serum IL-17 Correlated With Inflammatory Changes But Not With Bony Changes in Both Hand Osteoarthritis and Rheumatoid Arthritis
The total number of the included subjects was 120 in 3 equal groups (RA, OA and control). All subject was subjected to serum IL17 level measurement. MSK US (of both wrists, MCPs, PIPs and DIPs) was done to all patients in RA and OA groups. Disease activity was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
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 |
|---|---|---|
| Control group | Healthy volunteers with no symptoms or signs of rheumatoid arthritis or osteoarthritis | |
| Rheumatoid arthritis group | Rheumatoid arthritis (RA) patients fulfilled 2010 American college of rheumatology (ACR) classification criteria. A patient is considered having definite RA if he/she scores at least 6 points in the established classification system | |
| Osteoarthritis group | Osteoarthritis (OA) patients fulfilled 1990 ACR criteria for the classification and reporting of osteoarthritis of the hand. A patient is considered having hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical disease activity in Rheumatoid Arthritis (RA) and hand Osteoarthritis (OA) patients
During the whole course of the study, disease activity of the patients was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients.
Measured: 12 months
Secondary outcomes (1)
IL-17 serum levels in RA and OA patients
IL-17 will be measured by enzyme linked immunosorbent assay from collected serum samples from the study participants
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jul 2020
- Primary completion29 Nov 2020
- Study completion29 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA) and Osteoarthritis (OA)Studies of the same condition, open and under way.
- More trials run by Zagazig 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha M Hammad, MD, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474912
- Sponsor's protocol ID
- 6293-22-7-2020
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2020
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum IL-17 Correlated With Inflammatory Changes But Not With Bony Changes in Both Hand Osteoarthritis and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04474912
- Acronym / sponsor ID
- 6293-22-7-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 17 Jul 2020 (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.
The total number of the included subjects was 120 in 3 equal groups (RA, OA and control). All subject was subjected to serum IL17 level measurement. MSK US (of both wrists, MCPs, PIPs and DIPs) was done to all patients in RA and OA groups. Disease activity was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Healthy volunteers with no symptoms or signs of rheumatoid arthritis or osteoarthritis |
| Rheumatoid arthritis group | – | –Rheumatoid arthritis (RA) patients fulfilled 2010 American college of rheumatology (ACR) classification criteria. A patient is considered having definite RA if he/she scores at least 6 points in the established classification system |
| Osteoarthritis group | – | –Osteoarthritis (OA) patients fulfilled 1990 ACR criteria for the classification and reporting of osteoarthritis of the hand. A patient is considered having hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study participants will be recruited from attendants to Rheumatology and Rehabilitation outpatient clinic at Zagazig University Hospitals
Key inclusion criteria (2 listed)
- A patient is considered having definite RA if he/she scores at least 6 points in the established classification system
- A patient is considered having Hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands
Key exclusion criteria (1 listed)
- Any subject with liver diseases, coronary artery diseases, kidney diseases or other inflammatory conditions was excluded from the study.
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
Clinical disease activity in Rheumatoid Arthritis (RA) and hand Osteoarthritis (OA) patients
Time frame: 12 months
During the whole course of the study, disease activity of the patients was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients.
1 secondary outcome
IL-17 serum levels in RA and OA patients
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Related trials for Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
Not yet recruiting
Effect of Exercise Type on Muscle Quality in Patients With OA, SARC and RA: an Explorative Study
Rheumatoid Arthritis, Osteoarthritis
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) and Osteoarthritis (OA), run by Zagazig 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 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: finished, as of the sponsor's last update on 14 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical disease activity in Rheumatoid Arthritis (RA) and hand Osteoarthritis (OA) patients (time frame: 12 months). 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 14 Nov 2023.