rheumatoid arthritis (RA)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who are diagnosed with RA, based on the American College of Rheumatology criteria Patients who understand the conditions of the study and are willing and able to comply with the scheduled evaluations. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent surgery of the hand or fingers or who are expected to need surgery of the hand in due course 2. Patients with malignancy in the last 12 months 3. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the affected joint during the HR-pQCT evaluation. 4. Patients with known systemic or metabolic disorders leading to progressive bone deterioration such as: a. Primary hyperthyroidism b. Primary hyperparathyroidism c. Chronic kidney disease with eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is 1/ cross-sectionally - the prevalence of bone erosions and 2/ longitudinally - the progression of bone erosions in the 2nd and 3rd proximal interphalangeal (PIP) joints and metacarpophalangeal (MCP) joints of the hands bilaterally in patients with RA, and healthy controls only the dominant hand 2nd and 3rd PIP, MCP joints and including the 2nd and 3rd distal interphalangeal (DIP) joints, by using the HRpQCT (Total of 800 RA + 480 healthy control joints in the study + 120 joints of females with handosteoarthritis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the comparison of the number of joints with erosions detected by HRpQCT with 1/ the number of joints with erosions detected by X-rays, MRI and US and 2/ the number of joints with osteitis by MRI; exploring possibilities to quantify the 3-D joint space volume occupied by cartilage; and the correlation between the prevalence and progression of erosions with serum bone turnover markers. | — |
Countries
Netherlands