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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04190758
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Vastra Gotaland Region
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eva Klingberg, Assoc. ProfInger Gjertsson, Prof
Principal Investigator Affiliation Dep of Rheumatology and Inflammation research, University of Gothenburg, SwedenDep of Rheumatology and Inflammation research, University of Gothenburg, Sweden
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Psoriatic Arthritis, Arthritis, Psoriasis, Cardiovascular Diseases, Obesity, Lung Diseases
Arms & Interventions

Arms

: 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.

: Patients with psoriatic arthritis (PsA)

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

: 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

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

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

Interventions

Other: - Care as usual

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

Contact a Trial Team

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International Sites

Gothenburg, Sweden

Status

Recruiting

Address

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

Gothenburg, , 413 45

Site Contact

Eva Klingberg, Assoc. prof

eva.klingberg@vgregion.se

+46-313427745

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