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

NCT ID: NCT04190758

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 5100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2069-12-21

Brief 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

Rheumatoid Arthritis; Psoriatic Arthritis; Arthritis; Psoriasis; Cardiovascular Diseases; Obesity; Lung Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Care as usual

Intervention Type: OTHER

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

Patients with psoriatic arthritis (PsA)

Patients with PsA meeting the classification criteria of Classification for Psoriatic Arthritis (CASPAR).

Care as usual

Intervention Type: OTHER

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

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.

Care as usual

Intervention Type: OTHER

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

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.

Care as usual

Intervention Type: OTHER

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

General population controls

General population controls retrieved from the Population Register, matched for age, sex and residence of living to the included patients.

No interventions assigned to this group

Interventions

Care as usual

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Klingberg, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden

Inger Gjertsson, Prof

Role: PRINCIPAL_INVESTIGATOR

Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden

Locations

Clinical Rheumatology Research Center (CRRC), Department of Rheumatology, Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

VastraGotaland record 273244

Identifier Type: -

Identifier Source: org_study_id