An interventional study of Arthroscopic synovectomy of the wrist and Intra-articular corticosteroid injection in Wrist Arthritis, Psoriatic Arthritis and Rheumatoid Arthritis, sponsored by Maasstad Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by Maasstad Hospital · Not applicable, Interventional, and Treatment
Among 34 studies in Arthritis, Psoriatic with a site in Netherlands — 2 open to participants now, 6 under way, 2 of them phase 3. Arthritis, Psoriatic · Netherlands.
Among the 34 studies in Arthritis, Psoriatic with a site in Netherlands, this one is the 19th largest by planned enrollment of the 27 interventional ones, is one of 3 that started in 2021, is one of 2 with no phase, and was the 32nd registered.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 80 is below the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →2 of the 34 studies in Arthritis, Psoriatic with a site in Netherlands are open now, in 1 country. Each count lists the studies.
Of the 89 Arthritis, Psoriatic studies recruiting now, 54 (61%) set no upper age limit and 26 (29%) stop at 75 or younger; 12 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2021.
Median enrollment 200 across the 27 interventional studies, 304 across the 7 observational. Of the 27 that completed or were terminated, 20 (74%) have results posted.
27 of 34 have an industry lead sponsor. The 10 most frequent:
Maasstad Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Maasstad Hospital has 1 study filed under Arthritis, Psoriatic — fewer than ten, so there is no comparison to draw.
1 of the studies in Arthritis, Psoriatic with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05049798Janssen Pharmaceutica N.V., BelgiumA Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice | 2027-08-01 |
Among the 34 studies in Arthritis, Psoriatic with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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 function and reduced quality of life. The first line treatment usually consists of conventional Disease-Modifying Anti-Rheumatic Drugs (cDMARDs) along with bridging therapy using systemic corticosteroids or intra-articular corticosteroids in case of limited joint disease. After initiation therapy, intra-articular corticosteroids are often utilized as they provide rapid dampening of joint inflammation in case of a flare-up of disease activity (mono- or oligoarthritis). However, a substantial part of these patients clinically respond poorly or not at all. Alternatively, arthroscopic synovectomy may provide substantial relieve of symptoms, improve functionality, slow down disease progression and prevent joint destruction, as earlier studies have suggested. Prospective randomized studies are needed to confirm these findings. Moreover, they may prevent the need for expensive biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) and assist in guiding therapeutic strategies in the long run, through collecting and analysing valuable synovial biopsies. Wrist arthroscopy is a routine procedure in the participating centres with only minor complications and fast recovery.
Objective: To compare arthroscopic synovectomy with deposition of intra-articular corticosteroids (DIACS) versus intra-articular injection of corticosteroids (IACSI) in RA and PsA patients with mono- or oligoarthritis of the wrist that is refractory to cDMARD therapy.
Study design: Multi-centre randomized controlled trial conducted in the Maasstad Hospital and Spijkenisse Medisch Centrum (SMC).
Study population: Patients with active RA or PsA and bDMARD-naive, who develop a localized flare of disease activity (mono- or oligoarthritis) that involves the wrist, defined as an increase in DAS28 > 1.2 or > 0.6 if DAS28 ≥ 3.2 compared to the last DAS28 measurement (maximum six months before) and that is refractory to systemic cDMARD for at least three months, defined as no response on the European League Against Rheumatism (EULAR) response criteria.
Intervention: This study will randomize between IACSI of the wrist (control) and arthroscopic synovectomy of the wrist combined with DIACS (intervention). During arthroscopy synovial biopsies will be collected and stored for later analysis of the functional and histological characteristics of the synovium (beyond the scope of this study).
Main study parameters/endpoints: Primary outcome is the change in Patient-Rated Wrist Evaluation (PRWE) score from randomization to three months of follow-up. The PRWE is a validated, fifteen-item self-reported questionnaire rating wrist pain and function. Secondary outcomes are resolution of wrist arthritis measured by ultrasound, standard wrist radiographs, DAS28, EULAR response rate, Visual Analogue Scale (VAS), EQ-5D quality of life questionnaire, iMTA Productivity Cost Questionnaire (iPCQ), iMTA Medical Consumption Questionnaire (iMCQ), cost effectiveness analyses (CEA), physical examination, adverse events (AE) and laboratory results. Follow-up visits are scheduled at three, six and twelve months after intervention.
Nature and extent of the burden and risks associated with study participation:
Both study arms include standard treatment of care. Wrist arthroscopy is a standard treatment for wrist arthritis and often implemented for other intra-articular wrist pathology. The risks include infection, neurovascular damage and articular surface damage. Nevertheless, wrist arthroscopy is a well-established and safe technique. Reduction of risks will be done according to inclusion and exclusion criteria. If complications arise, the treating physician will proportionate the adequate treatment according to the current protocols based on the published literature. Patients will be asked to return at three, six and twelve months. These visits are standard of care following the rheumatic arthritis protocol. Patients will be asked to complete questionnaires at baseline and at three follow-up moments. These will take 160 minutes in total. The arthroscopy group will return between ten to fourteen days for wound inspection. All patient will be contacted by telephone at two, four and six weeks for VAS pain scores.
Expected results: We expect that arthroscopic synovectomy followed by DIACS will lead to significantly more improvement in PRWE scores compared to IACSI three months after intervention. Furthermore, we anticipate that wrist arthroscopy will result in lower pain scores, better joint mobility, better response on EULAR score, sustained resolution of arthritis on ultrasound, less joint damage on radiographs and is more cost-effective after one-year analysis.
Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Group 1. Inclusion criteria RA patients:
Group 2. Inclusion criteria PsA patients:
Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injection with 40mg triamcinolone acetonide (kenacort) in the wrist
Drug: Intra-articular corticosteroid injection
Wrist arthroscopy in day surgery setting with debulking of synovitis, inspection of cartilage, ligament, tendon and bone damage, collection of synovial biopsies and deposition of intra-articular corticosteroids (40mg triamcinolone acetonide)
Procedure: Arthroscopic synovectomy of the wrist
Wrist arthroscopy in day surgery setting with debulking of synovitis, inspection of cartilage, ligament, tendon and bone damage, collection of synovial biopsies and deposition of intra-articular corticosteroids (40mg triamcinolone acetonide)
Injection with 40mg triamcinolone acetonide (kenacort) in the wrist
Patient-Rated Wrist evaluation (PRWE)
15-item questionnaire scoring pain and wrist function on a scale from 0-100, with a higher score indicating worse outcome.
Time frame: 3 months
Patient-Rated Wrist evaluation (PRWE)
15-item questionnaire scoring pain and wrist function on a scale from 0-100, with a higher score indicating worse outcome.
Time frame: 6 and 12 months
Wrist ultrasound
Resolution of ultrasound (US) arthritis as defined by grey scale (B-mode) and power Doppler after three months compared to baseline measurement. Grey scale uses a two-dimensional image to visualize structural changes like synovial hypertrophy and bone erosions. Power Doppler mode can assess joint inflammatory activity by detecting pathological synovial blood flow. The EULAR-OMERACT (Outcome Measures in Rheumatology Clinical Trials) combined scoring system includes both greyscale and power Doppler and will be used to score arthritis in this study. Ultrasound has demonstrated greater sensitivity than clinical assessment and conventional radiography for detecting synovitis in RA target joints. Also, US signs of synovitis were found predictive for flare and failure of DMARD therapy, despite clinical remission. Furthermore, ultrasound techniques are low-invasive, inexpensive and require no radiation.
Time frame: 3 months
Wrist X-ray
Standard (plain) radiographs of the wrist at baseline and after twelve months. Arthritis on radiographs will be graded using the Modified Larsen grading system. This system grades wrist arthritis on a score of 0 to 5, 5 indicating the most joint abnormalities.
Time frame: 12 months
NRS pain score
Numeric Rating Scale (NRS) pain score at baseline two, four and six weeks (by phone), and at three, six and twelve months (digitally). A score of 0 implies no pain and 10 the worst possible pain.
Time frame: 2, 4 and 6 weeks, 3, 6 and 12 months
Range of motion
Range of motion (ROM) of the wrist at baseline, three, six and twelve months. ROM will be measured actively with a goniometer and includes pronation, supination, ulnar and radial deviation and palmar and dorsal flexion.
Time frame: 3, 6 and 12 months
Grip strength
Grip strength of the wrist at baseline, three, six and twelve months. Grip strength will be measured using a dynamometer as the mean of three measurements.
Time frame: 3, 6 and 12 months
DAS 28
EULAR response rate and Disease Activity Score (DAS28) at baseline, three, six and twelve months. The DAS28 is a measure of disease activity in rheumatoid arthritis in which 28 joints are examined for swelling and tenderness, combined with global pain scores and blood markers (www.DAS28-score.nl). The EULAR response rate measures responsiveness to anti-rheumatic treatment and is derived from the DAS28 score
Time frame: 3, 6 and 12 months
EQ-5D
EuroQol 5D (EQ-5D) at baseline, three, six and twelve months. The EQ-5D is a standardized questionnaire scoring quality of life on five different levels, on a scale from 0-100.
Time frame: 3, 6 and 12 months
iPCQ questionnaire
Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) at baseline, three, six and twelve months. The iPCQ is a standardized instrument for measuring and valuing health related productivity losses. This wil be used for the cost effectiveness analysis.
Time frame: 3, 6 and 12 months
iMCQ questionnaire
Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ) at baseline, three, six and twelve months. The iMCQ is a standardized instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers, medication use and home care. This wil be used for the cost effectiveness analysis.
Time frame: 3, 6 and 12 months
ESR
Laboratory test: erythrocyte sedimentation rate (ESR) at baseline and three, six and twelve months (part of the routine clinical care).
Time frame: 3, 6 and 12 months
CRP
Laboratory tests: C-reactive protein (CRP) at baseline and three, six and twelve months (part of the routine clinical care).
Time frame: 3, 6 and 12 months
Adverse events
Adverse events (AEs) (including glucocorticoid related AEs), AEs leading to withdrawal, AEs leading to discontinuation of medication, and AEs due to infusion reactions.
Time frame: One year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Dec 2025, 59 months after the start.
Of 67 non-industry interventional studies with no phase under Arthritis, Psoriatic, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 43. This study's planned 59 months is above that.
Counting every sponsor, half of 72 studies reached it within 31 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Maasstad Hospital