NCT04190758Enrolling by invitation
GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden
Source: ClinicalTrials.gov · Last updated 12 Oct 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
GÖTHA- The early arthritis and psoriasis study of Region Västra Götaland, Sweden - is a longitudinal observational study, which will prospectively and in parallel follow patients with newly diagnosed rheumatoid arthritis (RA, N=1000), psoriatic arthritis (PsA, N=500) and undifferentiated arthritis (N=100), together with patients with psoriasis (N=500). The study will also recruit healthy controls from the general population (N=3000). The aims of the study are to define predictors for disease course and severity, treatment response, comorbidities, health related quality of life (HRQoL) and health economy. The study is a collaboration between the department of Rheumatology and the department of Dermatology at Sahlgrenska University Hospital in Gothenburg, and the departments of Rheumatology at the hospitals of Alingsås, Borås, Uddevalla and Skövde, in the west of Sweden. All patients with newly diagnosed RA, PsA and undifferentiated arthritis at the Rheumatology centers are eligible for inclusion. Patients with psoriasis will be recruited from the Department of dermatology at Sahlgrenska University Hospital. The patients will be examined at baseline and at one, three, five and ten years. The assessments will include physical examination with evaluation of joints, entheses and skin and validated questionnaires regarding medical history, comorbidities, lifestyle, disease activity, bodily function, socioeconomic factors and HRQoL. Blood samples will be collected. The patients with arthritis will also undergo radiography of the lung, hands and feet, and Cone Beam Computed Tomography (CBCT) of hands and feet.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 5100 (estimated)
- First submitted
- 4 Dec 2019
- Start date
- 1 Jan 2020
- Primary completion date
- 31 Dec 2039
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Psoriasis, Obesity, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT04190758
What you commit to
- Study type: Observational
- Planned participants: 5100
- From 1 Jan 2020 to the primary completion date, 31 Dec 2039
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having other concomitant rheumatic diagnose (Sjögrens syndrome is not an exclusion criteria)
Other
- Inability to follow study protocol
- Swedish language difficulties
Who the study is looking for
- Patients with rheumatoid arthritis (RA) meeting the classification criteria of American College of Rheumatology (ACR) and/or European League Against Rheumatism (EULAR) från 2010
- Patients with psoriatic arthritis (PsA) meeting the classification criteria of Classification for Psoriatic Arthritis (CASPAR) PsA
- Patients with undifferentiated arthritis defined as a patients with a clear arthritis, but not meeting with established classifications criteria of any now known rheumatic disease
- Patients with psoriasis diagnosed at a dermatology department. The patients should not have any history of joint complaints with a duration of more than 6 weeks
- General population controls, matched for age, sex and residence of living to the included patients.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Rheumatology Research Center (CRRC), Department of Rheumatology, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.