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NCT04190758: GOTHA
GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden
trial testing Care as usual in Rheumatoid Arthritis in 5,100 participants. Enrolling by invitation.
31 December 2039
Quick facts
| Lead sponsor | Vastra Gotaland Region |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 5,100 |
| Start date | 1 January 2020 |
| Primary completion | 31 December 2039 |
| Estimated completion | 21 December 2069 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Care as usual — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Psoriatic Arthritis — all drugs for Psoriatic Arthritis →
- Arthritis — all drugs for Arthritis →
- Psoriasis — all drugs for Psoriasis →
Sponsor
Vastra Gotaland Region — full company profile →
Who can join
Adults 18 to 80, any sex, with Rheumatoid Arthritis or Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04190758
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04190758 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vastra Gotaland Region
- Last refreshed: 12 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04190758.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing