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

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04190758

Collaborator

(none)

5,100

Enrollment

Location

599.7

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Psoriatic Arthritis Arthritis Psoriasis Cardiovascular Diseases Obesity Lung Diseases	Other: Care as usual

Study Design

Study Type:

Observational

Anticipated Enrollment :

5100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2039

Anticipated Study Completion Date :

Dec 21, 2069

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Care as usual 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).	Other: Care as usual 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.	Other: Care as usual 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.	Other: Care as usual 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.

Outcome Measures

Primary Outcome Measures

Disease activity [12 months]
Disease Activity Score using 28 joint counts (DAS28) score range 0-9.07

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Rheumatology Research Center (CRRC), Department of Rheumatology, Sahlgrenska University Hospital	Gothenburg		Sweden	413 45

Sponsors and Collaborators

Vastra Gotaland Region

Investigators

Principal Investigator: Eva Klingberg, Assoc. Prof, Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden
Principal Investigator: Inger Gjertsson, Prof, Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden