Status:
UNKNOWN
Arthroscopic Synovectomy of the Wrist in Inflammatory Arthritis
Lead Sponsor:
Maasstad Hospital
Conditions:
Wrist Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Psoriatic (PsA) and rheumatoid arthritis (RA) are inflammatory joint diseases that often involve the wrist and may result in progressive joint destruction followed by impaired wrist functio...
Eligibility Criteria
Inclusion
- Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Male and female patients with age ≥ 18 years
- Subjects able and willing to give written informed consent (or legally acceptable representative or impartial witness when applicable) and is available for entire study
- Patients meet the criteria of either group below:
- Group 1. Inclusion criteria RA patients:
- Patients that are diagnosed with RA according to the revised 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Rheumatoid Arthritis Classification Criteria (table 1)
- Patients are experiencing an exacerbation defined as an increase in DAS28 \> 1.2 or \> 0.6 if DAS28 ≥ 3.2 compared to last DAS28 measurement (maximum six months before)
- The exacerbation is refractory to systemic cDMARDs for at least three months, defined as 'no response' according to the EULAR response criteria (table 2)
- Wrist arthritis, that is diagnosed clinically, is the predominant symptom
- Group 2. Inclusion criteria PsA patients:
- Patients that are diagnosed with PsA according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (table 3)
- Patients are experiencing an exacerbation defined as an increase in DAS28 \> 1.2 or \> 0.6 if DAS28 ≥ 3.2 compared to last DAS28 measurement (maximum six months before)
- The exacerbation is refractory to systemic cDMARDs for at least three months, defined as 'no response' according to the EULAR response criteria (table 2)
- Wrist arthritis, that is diagnosed clinically, is the predominant symptom
- Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous or current treatment with biological (b) DMARDs
- Current inflammatory joint disease other than RA or PsA (e.g. gout, reactive arthritis, Lyme disease)
- Subjects who are pregnant or intend to become pregnant during the study
- Intra-articular corticosteroids injection in the wrist in the last 6 months
- Previous wrist surgery
- Severe osteoarthritis with malformations of the wrist
- Congenital abnormalities of wrist function or motion
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04755127
Start Date
January 1 2021
End Date
December 31 2025
Last Update
December 28 2023
Active Locations (1)
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1
Maasstad Hospital
Rotterdam, South Holland, Netherlands, 3079 DZ