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

Launched by VASTRA GOTALAND REGION · Dec 6, 2019

Keywords

ClinConnect Summary

GÖTHA is a long-term, observational study in western Sweden that follows people who are newly diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA), other arthritis conditions, or psoriasis, along with a group of healthy adults. The goal is to understand how these diseases progress in real life, what factors predict how severe they become, how well treatments work in everyday care, and how the conditions affect quality of life and healthcare costs. The researchers will mainly look at disease activity after about one year using a standard score called DAS28 and will continue to track outcomes over up to ten years. Participants will provide blood samples (and, at baseline, stool samples) and arthritis patients will have imaging tests of the hands/feet and lungs as part of regular care.

Who can join? Adults aged 18 to 80 who are newly diagnosed with RA, PsA, or undifferentiated arthritis (arthritis that doesn’t yet fit a specific category), or adults with psoriasis diagnosed in dermatology care (without joint symptoms lasting more than six weeks) can be eligible. Healthy volunteers from the general population, matched by age, sex, and where they live, are also invited. The study plans to enroll about 5,100 people in total: roughly 1,000 with RA, 500 with PsA, 100 with undifferentiated arthritis, 500 with psoriasis, and about 3,000 healthy controls. Participants will have study visits at baseline, and then at 1, 3, 5, and 10 years, including exams, questionnaires, blood tests, and imaging tests for arthritis patients. There is no experimental treatment involved; all care is standard medical care, while the study collects information to improve understanding of these diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Inability to follow study protocol
• • Swedish language difficulties
• • Having other concomitant rheumatic diagnose (Sjögrens syndrome is not an exclusion criteria)