Rheumatoid ArthritisGOTHANCT04190758
GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Arthritis
- What is being tested?
- Care as usual
- How many people
- 5,100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 21 Dec 2069
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Inability to follow study protocol
- Swedish language difficulties
- Having other concomitant rheumatic diagnose (Sjögrens syndrome is not an exclusion criteria)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Clinical Rheumatology Research Center (CRRC), Department of Rheumatology, Sahlgrenska University Hospital
Gothenburg, 413 45
About this study
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.
Read more
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
- Being tested
- Care as usual
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Arthritis, Psoriasis, Cardiovascular Diseases, Obesity, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care as usualOther
No intervention will be given. The study will follow the effects of care as usual.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Care as usual | |
| Patients with psoriatic arthritis (PsA) | Patients with PsA meeting the classification criteria of Classification for Psoriatic Arthritis (CASPAR). Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
Disease Activity Score using 28 joint counts (DAS28) score range 0-9.07
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2039 (estimated)
- Study completion21 Dec 2069 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eva Klingberg, Assoc. Prof, Principal investigator, Dep of Rheumatology and Inflammation research, University of Gothenburg, SwedenInger Gjertsson, Prof, Principal investigator, Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190758
- Sponsor's protocol ID
- VastraGotaland record 273244
- Acronym
- GOTHA
- Status last verified
- Oct 2021
- First submitted
- 4 Dec 2019
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden
- ClinicalTrials.gov ID
- NCT04190758
- Acronym / sponsor ID
- GOTHA / VastraGotaland record 273244
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Arthritis, Psoriasis, Cardiovascular Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,100 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2039 (estimated)
- Study completion
- 21 Dec 2069 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis (RA) | – | Other: Care as usualPatients 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) | – | Other: Care as usualPatients with PsA meeting the classification criteria of Classification for Psoriatic Arthritis (CASPAR). |
| Patients with undifferentiated arthritis | – | Other: Care as usualDefined as a patients with a clear arthritis, but not meeting with established classifications criteria of any now known rheumatic disease. |
| Patients with psoriasis | – | Other: Care as usualPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to follow study protocol
- Swedish language difficulties
- Having other concomitant rheumatic diagnose (Sjögrens syndrome is not an exclusion criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care as usualNo intervention will be given. The study will follow the effects of care as usual. | Other | Patients with psoriasis, Patients with psoriatic arthritis (PsA), Patients with rheumatoid arthritis (RA), Patients with undifferentiated arthritis |
Primary outcome
Disease activity
Time frame: 12 months
Disease Activity Score using 28 joint counts (DAS28) score range 0-9.07
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Klingberg, Assoc. Prof principal investigator
Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden
Inger Gjertsson, Prof principal investigator
Dep of Rheumatology and Inflammation research, University of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.