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

October 11, 2021 updated by: Vastra Gotaland Region

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Clinical Rheumatology Research Center (CRRC), Department of Rheumatology, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients at any of the involved rheumatology clinics with newly diagnosed RA, PsA or undifferentiated arthritis meeting the study criteria are eligible for inclusion.

Consecutive sampling

Patients with psoriasis diagnosed at a dermatology clinic. Consecutive sampling

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 12 months
Disease Activity Score using 28 joint counts (DAS28) score range 0-9.07
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2039

Study Completion (ANTICIPATED)

December 21, 2069

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (ACTUAL)

December 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VastraGotaland record 273244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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