Rheumatoid Arthritis (RA) and Osteoarthritis (OA) Clinical Trial
Official title:
Serum IL-17 Correlated With Inflammatory Changes But Not With Bony Changes in Both Hand Osteoarthritis and Rheumatoid Arthritis
| Verified date | November 2023 |
| Source | Zagazig University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | November 29, 2020 |
| Est. primary completion date | November 29, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Zagazig University Faculty of Medicine | Zagazig | Sharqia |
| Lead Sponsor | Collaborator |
|---|---|
| Zagazig University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Radiologic bony changes in RA and OA patients | During the whole course of the study period, recruited participants undergone musculoskeletal (MSK) ultrasound to assess the bony changes. | 12 months | |
| Primary | 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. | 12 months | |
| Secondary | 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 | 2 weeks |