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

NCT04190758 | Enrolling By Invitation

• 1 other identifier: VastraGotaland record 273244
• Study Type: observational
• Target: 5,100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Disease activity

  Disease Activity Score using 28 joint counts (DAS28) score range 0-9.07

  12 months

Study Arms (5)

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

Patients with psoriatic arthritis (PsA)

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

Other: 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

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

General population controls

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

Interventions

Care as usual OTHER

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

Patients with psoriasis; Patients with psoriatic arthritis (PsA); Patients with rheumatoid arthritis (RA); Patients with undifferentiated arthritis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Inability to follow study protocol
• Swedish language difficulties

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

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

Gothenburg, 413 45, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma will be sampled at each study visit. DNA and RNA tubes and fecal samples will be collected at baseline.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 9, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 31, 2039
• Study Completion (Estimated): December 21, 2069
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

SE (1)