- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474912
Serum IL-17 Correlated With Inflammatory Changes in Osteoarthritis and Rheumatoid Arthritis
November 12, 2023 updated by: Noha M Hammad, MD, Zagazig University
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
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sharqia
-
Zagazig, Sharqia, Egypt, 44519
- Zagazig University Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study participants will be recruited from attendants to Rheumatology and Rehabilitation outpatient clinic at Zagazig University Hospitals
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any subject with liver diseases, coronary artery diseases, kidney diseases or other inflammatory conditions was excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-17 serum levels in RA and OA patients
Time Frame: 2 weeks
|
IL-17 will be measured by enzyme linked immunosorbent assay from collected serum samples from the study participants
|
2 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiologic bony changes in RA and OA patients
Time Frame: 12 months
|
During the whole course of the study period, recruited participants undergone musculoskeletal (MSK) ultrasound to assess the bony changes.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
November 29, 2020
Study Completion (Actual)
November 29, 2020
Study Registration Dates
First Submitted
July 13, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 17, 2020
Study Record Updates
Last Update Posted (Actual)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 12, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6293-22-7-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
-
AstraZenecaCompletedOsteoarthritis (OA) | Rheumatoid Arthritis (RA) | Ankylosing Spondylitis (AS)Mexico, Vietnam, Malaysia, Argentina, Philippines, Korea, Republic of, Venezuela, Colombia, Russian Federation, Thailand
-
Second Affiliated Hospital of Wenzhou Medical UniversityNot yet recruitingKnee Osteoarthritis | Rheumatoid Arthritis (RA)
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedKnee Osteoarthritis | Rheumatoid Arthritis (RA) | Cardiovascular Disease RiskTurkey (Türkiye)
-
Middlesex UniversityRecruitingOsteoarthritis | Osteoarthritis (OA) | Osteoarthritis (OA) of the Knee | Osteoarthritis (OA) of the HipUnited Kingdom
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis (RA) | Arthritis, Rheumatoid (RA)United States
-
LinkBio Corp.Enrolling by invitationRheumatoid Arthritis | Fracture | Osteoarthritis (OA) of the KneeUnited States
-
Assiut UniversityNot yet recruitingOA | Osteearthritis | OA Knee
-
Université de SherbrookeHopital Charles LemoyneNot yet recruitingArthritis | Osteoarthritis | Gonarthrosis; Primary | Osteoarthritis of Knee | Osteoarthritis Knee Pain | OA Knee Pain | OA | Arthritis (Knee) | OA Knee
-
Cedars-Sinai Medical CenterNot yet recruiting
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada