Ankylosing SpondylitisNCT07580092
Construct Validity and Responsiveness of EQ-5D-3L and EQ-5D-5L in Patients With Inflammatory Joint Disease
An observational study of Ankylosing Spondylitis and Rheumatoid Arthritis (RA), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to compare the construct validity (convergent validity and known-groups validity) and responsiveness of EQ-5D-3L and EQ-5D-5L in patients with inflammatory joint disease. The study is based on prospectively collected data through the Swedish Rheumatology Quality Register (SRQ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Rheumatoid Arthritis (RA), Psoriatic Arthritis
- What is being tested?
- EQ-5D-5L
- How many people
- 6,967 participants
- Where
- 1 siteSweden
- Study dates
- 30 Nov 2023to 5 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory joint disease complete PROMs routinely in conjunction with their follow-up healthcare visits, through an online platform called Patients Own Registration (PER). Patients who meet the inclusion criteria will be asked whether they want to participate in the study when they access PER.
Who may be able to join
- Agreed to participate in the study
- ≥18 years at the time of the first measurement
- A diagnosis of rheumatoid arthritis (RA), polyarthritis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS)
- Complete registration of responses in the EQ-5D-3L and EQ-5D-5L descriptive system at least at one time point (one visit)
- For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as the EQ-5D was registered
- For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as the EQ-5D was registered
- For patients with PsA: At least one measurement with DAS28 or Disease Activity in Psoriatic Arthritis (DAPSA) reported in relation to the same visit as the EQ-5D was registered
- For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or the Axial Spondyloarthritis Disease Activity Score (ASDAS) reported in relation to the same visit as the EQ-5D was registered
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the construct validity (convergent validity and known-groups validity) and responsiveness of EQ-5D-3L and EQ-5D-5L in patients with inflammatory joint disease. The study is based on prospectively collected data through the Swedish Rheumatology Quality Register (SRQ).
Read the detailed description
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
- Conditions
- Ankylosing Spondylitis, Rheumatoid Arthritis (RA), Psoriatic Arthritis, Polyarthritis, Inflammatory Joint Disease (IJD)
- Being tested
- EQ-5D-5L
- Keywords
- measurement properties, psychometric properties, inflammatory joint disease, eq-5d
- Medical subject headings
- Spondylitis, Ankylosing, Arthritis, Rheumatoid, Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ-5D-5LOther
EQ-5D is a generic instrument used to measure, value, and compare health across symptoms and diagnoses. There are two versions of the EQ-5D, the EQ-5D-3L and the EQ-5D-5: Patients with inflammatory joint disease already complete patient-reported measures (PROMs), including EQ-5D-3L, routinely in conjunction with their follow-up healthcare visits, and patients who consent to participate in the study will also complete the EQ-5D-5L. The order in which the patient responds to the EQ-5D-3L and EQ-5D-5L is randomised so that participants answer one version of the EQ-5D before the other routinely collected PROMs, and the other EQ-5D version at the end. When data collection with EQ-5D-5L is concluded, all data necessary for analyses will be retrieved from the SRQ.
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-3L
Instrument used to measure and value health-related quality of life. The instrument consists of five items/dimensions that can be answered from 1-3. A higher score indicates more problems. The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
EQ-5D-5L
Instrument used to measure and value health-related quality of life. The instrument consists of five items/dimensions that can be answered from 1-5. A higher score indicates more problems. The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Disease activity score 28 (DAS28)
Measure of disease activity. 0 indicates no disease activity and 10 indicates the highest disease activity.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measure of disease activity. 0 indicates no disease activity and 10 highest disease activity.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Measure of disease activity. 0 indicates no disease activity. There is no upper limit, but a higher score indicates higher disease activity.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Health Assessment Questionnaire Disability Index (HAQ-DI)
Measure of physical function. Ranges between 0 and 3. A higher score indicates more problems with physical function.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Bath Ankylosing Spondylitis Functional Index (BASFI)
Measure of physical function. Ranges between 0 and 10. A higher score indicates more problems with physical function.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Pain measured with a visual analogue scale
Visual analogue scale measuring pain. 0 indicates no pain and 100 indicates the worst possible pain.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Fatigue measured with a visual analogue scale
Visual analogue scale measuring fatigue. 0 indicates no problem with fatigue and 100 indicates the worst possible fatigue.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
General health measured with a visual analogue scale
Visual analogue scale measuring general health. 0 indicates no problems with general health and 100 indicates worst possible general health.
Measured: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Nov 2023
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 6,967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, The EuroQol Research Foundation
- Responsible party
- Principal investigator, Emelie Heintz, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580092
- Sponsor's protocol ID
- Dnr 2022-04211-01
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchholz I, Thielker K, Feng YS, Kupatz P, Kohlmann T. Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Qual Life Res. 2015 Apr;24(4):829-35. doi: 10.1007/s11136-014-0838-x. Epub 2014 Oct 30.
PubMed 25355653Devlin NJ, Parkin D, Browne J. Patient-reported outcome measures in the NHS: new methods for analysing and reporting EQ-5D data. Health Econ. 2010 Aug;19(8):886-905. doi: 10.1002/hec.1608.
PubMed 20623685Bas Janssen MF, Birnie E, Bonsel GJ. Evaluating the discriminatory power of EQ-5D, HUI2 and HUI3 in a US general population survey using Shannon's indices. Qual Life Res. 2007 Jun;16(5):895-904. doi: 10.1007/s11136-006-9160-6. Epub 2007 Feb 10.
PubMed 17294285Gulfe A, Geborek P, Saxne T. Response criteria for rheumatoid arthritis in clinical practice: how useful are they? Ann Rheum Dis. 2005 Aug;64(8):1186-9. doi: 10.1136/ard.2004.027649. Epub 2005 Mar 10.
PubMed 15760931Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001.
PubMed 19962619Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016 May;75(5):811-8. doi: 10.1136/annrheumdis-2015-207507. Epub 2015 Aug 12.
PubMed 26269398Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, and interpretation. J Exp Psychol Gen. 2012 Feb;141(1):2-18. doi: 10.1037/a0024338. Epub 2011 Aug 8.
PubMed 21823805Thyberg I, Dahlstrom O, Bjork M, Arvidsson P, Thyberg M. Potential of the HAQ score as clinical indicator suggesting comprehensive multidisciplinary assessments: the Swedish TIRA cohort 8 years after diagnosis of RA. Clin Rheumatol. 2012 May;31(5):775-83. doi: 10.1007/s10067-012-1937-0. Epub 2012 Jan 17.
PubMed 22249375Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
PubMed 12831398Boonen A, van der Heijde D, Landewe R, van Tubergen A, Mielants H, Dougados M, van der Linden S. How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis? Ann Rheum Dis. 2007 Jun;66(6):771-7. doi: 10.1136/ard.2006.060384. Epub 2007 Jan 9.
PubMed 17213254Aletaha D, Smolen JS. The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007 Aug;21(4):663-75. doi: 10.1016/j.berh.2007.02.004.
PubMed 17678828Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5.
PubMed 7699629Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137-45. doi: 10.1002/art.1780230202.
PubMed 7362664Lukas C, Landewe R, Sieper J, Dougados M, Davis J, Braun J, van der Linden S, van der Heijde D; Assessment of SpondyloArthritis international Society. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Jan;68(1):18-24. doi: 10.1136/ard.2008.094870. Epub 2008 Jul 14.
PubMed 18625618Calin A, Nakache JP, Gueguen A, Zeidler H, Mielants H, Dougados M. Defining disease activity in ankylosing spondylitis: is a combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? Rheumatology (Oxford). 1999 Sep;38(9):878-82. doi: 10.1093/rheumatology/38.9.878.
PubMed 10515650
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Responsiveness of EQ-5D-3L and EQ-5D-5L in Patients With Inflammatory Joint Disease
- ClinicalTrials.gov ID
- NCT07580092
- Acronym / sponsor ID
- Dnr 2022-04211-01
- Conditions
- Ankylosing Spondylitis, Rheumatoid Arthritis (RA), Psoriatic Arthritis, Polyarthritis, Inflammatory Joint Disease (IJD)
- Keywords
- measurement properties, psychometric properties, inflammatory joint disease, eq-5d
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,967 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, The EuroQol Research Foundation
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 12 May 2026 (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.
The aim of this study is to compare the construct validity (convergent validity and known-groups validity) and responsiveness of EQ-5D-3L and EQ-5D-5L in patients with inflammatory joint disease. The study is based on prospectively collected data through the Swedish Rheumatology Quality Register (SRQ).
Detailed description
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory joint disease complete PROMs routinely in conjunction with their follow-up healthcare visits, through an online platform called Patients Own Registration (PER). Patients who meet the inclusion criteria will be asked whether they want to participate in the study when they access PER.
Key inclusion criteria (8 listed)
- Agreed to participate in the study
- ≥18 years at the time of the first measurement
- A diagnosis of rheumatoid arthritis (RA), polyarthritis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS)
- Complete registration of responses in the EQ-5D-3L and EQ-5D-5L descriptive system at least at one time point (one visit)
- For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as the EQ-5D was registered
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EQ-5D-5LEQ-5D is a generic instrument used to measure, value, and compare health across symptoms and diagnoses. There are two versions of the EQ-5D, the EQ-5D-3L and the EQ-5D-5: Patients with inflammatory joint disease already complete patient-reported measures (PROMs), including EQ-5D-3L, routinely in conjunction with their follow-up healthcare visits, and patients who consent to participate in the study will also complete the EQ-5D-5L. The order in which the patient responds to the EQ-5D-3L and EQ-5D-5L is randomised so that participants answer one version of the EQ-5D before the other routinely collected PROMs, and the other EQ-5D version at the end. When data collection with EQ-5D-5L is concluded, all data necessary for analyses will be retrieved from the SRQ. | Other | – |
Primary outcome
EQ-5D-3L
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Instrument used to measure and value health-related quality of life. The instrument consists of five items/dimensions that can be answered from 1-3. A higher score indicates more problems. The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead.
EQ-5D-5L
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Instrument used to measure and value health-related quality of life. The instrument consists of five items/dimensions that can be answered from 1-5. A higher score indicates more problems. The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead.
Disease activity score 28 (DAS28)
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Measure of disease activity. 0 indicates no disease activity and 10 indicates the highest disease activity.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Measure of disease activity. 0 indicates no disease activity and 10 highest disease activity.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Measure of disease activity. 0 indicates no disease activity. There is no upper limit, but a higher score indicates higher disease activity.
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Measure of physical function. Ranges between 0 and 3. A higher score indicates more problems with physical function.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Measure of physical function. Ranges between 0 and 10. A higher score indicates more problems with physical function.
Pain measured with a visual analogue scale
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Visual analogue scale measuring pain. 0 indicates no pain and 100 indicates the worst possible pain.
Fatigue measured with a visual analogue scale
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Visual analogue scale measuring fatigue. 0 indicates no problem with fatigue and 100 indicates the worst possible fatigue.
General health measured with a visual analogue scale
Time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
Visual analogue scale measuring general health. 0 indicates no problems with general health and 100 indicates worst possible general health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 25355653Buchholz I, Thielker K, Feng YS, Kupatz P, Kohlmann T. Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Qual Life Res. 2015 Apr;24(4):829-35. doi: 10.1007/s11136-014-0838-x. Epub 2014 Oct 30.
- Background: PubMed 20623685Devlin NJ, Parkin D, Browne J. Patient-reported outcome measures in the NHS: new methods for analysing and reporting EQ-5D data. Health Econ. 2010 Aug;19(8):886-905. doi: 10.1002/hec.1608.
- Background: PubMed 17294285Bas Janssen MF, Birnie E, Bonsel GJ. Evaluating the discriminatory power of EQ-5D, HUI2 and HUI3 in a US general population survey using Shannon's indices. Qual Life Res. 2007 Jun;16(5):895-904. doi: 10.1007/s11136-006-9160-6. Epub 2007 Feb 10.
- Background: PubMed 15760931Gulfe A, Geborek P, Saxne T. Response criteria for rheumatoid arthritis in clinical practice: how useful are they? Ann Rheum Dis. 2005 Aug;64(8):1186-9. doi: 10.1136/ard.2004.027649. Epub 2005 Mar 10.
- Background: PubMed 19962619Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001.
- Background: PubMed 26269398Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016 May;75(5):811-8. doi: 10.1136/annrheumdis-2015-207507. Epub 2015 Aug 12.
- Background: PubMed 21823805Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, and interpretation. J Exp Psychol Gen. 2012 Feb;141(1):2-18. doi: 10.1037/a0024338. Epub 2011 Aug 8.
- Background: PubMed 22249375Thyberg I, Dahlstrom O, Bjork M, Arvidsson P, Thyberg M. Potential of the HAQ score as clinical indicator suggesting comprehensive multidisciplinary assessments: the Swedish TIRA cohort 8 years after diagnosis of RA. Clin Rheumatol. 2012 May;31(5):775-83. doi: 10.1007/s10067-012-1937-0. Epub 2012 Jan 17.
- Background: PubMed 12831398Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
- Background: PubMed 17213254Boonen A, van der Heijde D, Landewe R, van Tubergen A, Mielants H, Dougados M, van der Linden S. How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis? Ann Rheum Dis. 2007 Jun;66(6):771-7. doi: 10.1136/ard.2006.060384. Epub 2007 Jan 9.
- Background: PubMed 17678828Aletaha D, Smolen JS. The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007 Aug;21(4):663-75. doi: 10.1016/j.berh.2007.02.004.
- Background: PubMed 7699629Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ankylosing Spondylitis and Rheumatoid Arthritis (RA), run by Karolinska Institutet 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 12 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EQ-5D-3L (time frame: Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07580092, which also lists 28 linked publications.
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 May 2026.