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

NCT04190758 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 5100

Last updated 2021-10-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Care as usual

No intervention will be given. The study will follow the effects of care as usual.

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Eva Klingberg, Assoc. Prof · Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden

  • Inger Gjertsson, Prof · Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2039-12-31
Completion
2069-12-21

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190758 on ClinicalTrials.gov