GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden

Sponsor
Vastra Gotaland Region
Study ID
NCT04190758
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Care as usual — OTHER
    No intervention will be given. The study will follow the effects of care as usual.

Study Details

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.

Key Dates

First listed
Dec 9, 2019
Start date
Jan 1, 2020
Status verified
Oct 2021
Primary completion
Dec 31, 2039
Completion
Dec 21, 2069

Study Design

Enrollment
5,100 participants (estimated)

Arms

  • Arm: Patients with rheumatoid arthritis (RA)
    Patients with RA meeting the classification criteria of American College of Rheumatology (ACR) and/or European League Against Rheumatism (EULAR) från 2010.
  • Arm: Patients with psoriatic arthritis (PsA)
    Patients with PsA meeting the classification criteria of Classification for Psoriatic Arthritis (CASPAR).
  • Arm: 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.
  • Arm: Patients with psoriasis
    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.
  • Arm: General population controls
    General population controls retrieved from the Population Register, matched for age, sex and residence of living to the included patients.

Primary Outcome Measure

Disease activity [ Time Frame: 12 months ]

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