Rheumatoid ArthritisNCT05463666
STudying Ageing in Rheumatic Diseases (STAR)
An observational study of Rheumatoid Arthritis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The primary objective of the STAR study is to investigate how measures of disease activity and measures for cognition, physical activity and performance behave in ageing population controls and patients with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rheumatoid arthritis
- How many people
- 840 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to Dec 2027
- 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 55 to 85 years
- All sexes
- Adult, Older adult
Study population: RA patients for the STAR project will be recruited from the outpatient clinics of the MUMC and the Zuyderland Medical Center in Heerlen / Sittard by the rheumatologist. The control population will be recruited through friends and/or family members of patients and controls, snowball sampling; a qualified participant can share an invitation with other subjects similar to them, and recruitment via patient partners of the MUMC. Moreover, patients and controls will be recruited by giving a presentation about the study during a gathering of patients and their family at the Reumacafé, dissemination of flyers during regular information evening of the department of rheumatology at the MUMC and Zuyderland, and recruit via local social (sports) clubs.
Who may be able to join
- Age between 55-85 years at baseline.
- Diagnosis of RA by treating rheumatologist.
- Age between 55-85 years at baseline.
- No diagnosis of RA, or other inflammatory RMD (osteoarthritis allowed).
Who cannot join
- Subject is the spouse/partner of the included RA patient.
- Have severe comorbidity and the treating rheumatologist and/or research team decides they should not be included in the study because of health reasons.
- A diagnosis of dementia or mental incompetency is always reason for exclusion.
- Persons of whom the research team estimates that his/her life expectancy is less than 2 years.
- Do not understand the Dutch language and/or are notable to understand the study information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ageing on Interpretation of Disease Activity Measures and on Cognition, Physical Activity and Performance in Patients With Rheumatic Disorders
The primary objective of the STAR study is to investigate how measures of disease activity and measures for cognition, physical activity and performance behave in ageing population controls and patients with rheumatoid arthritis (RA). If an differential effect of age on outcome over time is apparent, the presence of an inclination point will be assessed. The secondary objective is to investigate additional factors (e.g. lifestyle factors) that might explain any differences between ageing controls and RA patients.
The STAR study is an observational cross-sectional matched case-control study including 420 RA patients and 420 population controls between 55-85 years of age, stratified by five year intervals. All participants will complete generic and RA-specific questionnaires. A subset of 180 participants will be visiting the research center for physical examination and performance tests. Expected outcomes include practical age-specific reference curves that will be constructed for a selection of outcomes (e.g. DAS28).
It is expected that as RA is characterized by tender and painful joints, e.g. the number of tender joints has a higher starting point in RA patients than in the general population. This will most likely increase in both groups with age, although the general population may catch up at an older age. Measures of cognitive status may show a steeper decline with age in RA patients compared to the general population. Measures of physical activity and performance will presumably have a worse starting point in RA patients than in the general population, and might show a steep decline with age. The general population might however catch up with the patients with RA. Most probably, age will not be the only factor explaining 'worse' outcomes in both RA patients and the general population. Other factors such as lifestyle factors (e.g. smoking, diet, BMI, occupation) and comorbidities will probably play a role.
Read the detailed description
Rationale:
As the population ages and the lifespan of people with rheumatoid arthritis (RA) extends, more insight into the effect of ageing on RA is needed. Currently, it is unclear whether ageing has an impact on the interpretation of disease activity measures, specifically the (components of the) DAS28. In addition, the effect of RA on cognitive function, physical activity and performance, three outcomes that will influence treatment decisions, is underinvestigated.
Objectives:
The objectives of this study are to gain insight into the effect of ageing on the result of disease activity measures, decline in cognition, physical activity and performance. A first step towards such understanding is construction of population reference curves in function of age. These curves can be used to discern whether the change in an outcome measure can be explained by age. If age is the only important factor, a similar change in the age-specific curve of both the population and RA patients would be observed. In case of differences in the curve inclination point, it is of interest exploring variables explaining such differences (e.g. lifestyle factors).
Study design:
Observational cross-sectional matched case-control study.
Study population:
In total, 420 RA patients and 420 population controls between 55 and 85 years of age, stratified according to age at five year intervals, will be included.
Main study parameters/endpoints:
A total of 840 participants will complete generic and RA-specific questionnaires. Out of these 840 participants, 180 (21%) will also visit the research center for a physical examination and performance tests. Reference curves will be constructed according to the method described by Wright and Royston for among others components of the DAS28. In case of a difference between population controls and RA patients, the investigators will further explore to gain insight which variables explain the difference.
Statistical analyses:
Total test scores will be computed for each questionnaire. Subsequently, descriptive statistics i.e. the mean, SD and range of each questionnaire will compared. Continuous determinants including biomarkers (e.g. ESR and CRP) will be presented as either mean with corresponding standard deviation for normally and median with corresponding inter-quartile range for non-normally distributed variables. Dichotomous determinants, including fulfillment of criteria, will be presented as N (%).
For the primary objective, reference curves will be developed by using data of the population controls by the method described by Wright and Royston (modelling variables as fractional polynomial functions of age). By including 70 patients per 5-year interval, reference curves can reliably be constructed. Reference curves will, if needed, be adjusted for comorbidity level and gender, when this adjustment improves substantially the fit of the data; otherwise, the model will be kept as simple as possible, which also contributes to their more feasible application in practice. The data from RA patients will be 'plotted' in population reference curves.
For the secondary objective, exploratory analyses of factors associated with ≥2 standard deviations (SD) (or Z-scores) change from the population average, will be performed for the outcomes of interest (disease activity measures, cognition, physical activity and performance). Univariate analysis is used for variable selection: logistic regression techniques (after checking assumptions) will be applied to test the association between age and other covariates (example: RA disease duration, lifestyle factors or differences in socio-economic background) on the outcomes (≥2 SD below reference value) of interest. A p-value below 0.05 is set to indicate a statistically significant difference. Next multivariable regression analyses will be performed with the same outcomes while forcing age into the models and further including all univariately significant covariates in a hierarchical approach (after checking co-linearity).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All participants need to complete generic and RA-specific questionnaires. Patients > 80 years who are physically unable to complete the whole study procedure (i.e. geriatric patients who are considered frail by the rheumatologist / researcher and/or patient itself), are allowed to undergo only part of the study measurements / questionnaires.
All 180 patients and controls will be seen in one study visit by 1-2 trained research assistant(s), using standardized protocols. Participants will undergo a physical examination, physical and laboratory (three blood samples; one venepuncture) testing.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rheumatoid arthritis
- Keywords
- ageing, elderly, reference curves, rheumatic disease, disease activity measures, cognitive function, physical activity, physical performance, treatment
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheumatoid arthritisOther
A diagnosis of rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Population controls | Participants between 55 and 85 years of age without a diagnosis of RA, or other inflammatory RMD (osteoarthritis allowed). Controls > 80 years who are physically unable to complete the whole study procedure, are allowed to undergo only part of the study measurements. | |
| RA patients | Participants between 55 and 85 years of age with a diagnosis of RA by the treating rheumatologist. Patients > 80 years who are physically unable to complete the whole study procedure, are allowed to undergo only part of the study measurements. Receives: Other: Rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age-specific reference curve Disease Activity Score (DAS)28
Age-specific reference curve for components of the DAS28 (in subgroup). The DAS28 refers to 28 joints that examined in this assessment. Scores vary between 0-10, where higher DAS28 scores indicate a higher disease activity.
Measured: Day 1
Age-specific reference curve Routine Assessment of Patient Index Data (RAPID)3 / Health Assessment Questionnaire (HAQ)2
Age-specific reference curve for question 3 and 6 of the RAPID3/Multidimensional HAQ2. The RAPID3 scores vary between 0-30, where higher scores indicate poorer status.
Measured: Day 1
Age-specific reference curve Telephone Interview Cognitive Status (TICS)
Age-specific reference curve for the TICS. Total scores vary between 0-50, where a score below <34 or <28 may indicate a neurocognitive disorder as mild cognitive impairment (MCI) or dementia.
Measured: Day 1
Age-specific reference curve Health Assessment Questionnaire (HAQ)
Age-specific reference curve for the HAQ. The HAQ is a questionnaire including 20 items in eight domains that measure difficulties in performing daily activities, where each question is rated on a scale from 0 to 3. A higher total score indicates higher disability in performing daily activities.
Measured: Day 1
Age-specific reference curve timed stand chair test
Age-specific reference curve for the timed stand chair test (in subgroup).
Measured: Day 1
Secondary outcomes (5)
Age-specific reference curves for the Fried criteria
Age-specific reference curves for the Fried criteria, which include several criteria to define a frail patient (low grip strength, unintentional weight loss, self-reported exhaustion, low physical activity and slower walking speed). At least three of five criteria have to be present to classify the patient as being frail.
Measured: Day 1
Age-specific reference curves for the Groningen Frailty Indicator
Age-specific reference curves for the Groningen Frailty Indicator, which is a 15-item questionnaire with a score ranging from 0-15. A sum score of 4 or more means the patient can be considered as being frail.
Measured: Day 1
Age-specific reference curves for the General Anxiety Disorder (GAD)7
Age-specific reference curves for the GAD-7, a seven-item questionnaire with a total score ranging from 0-21. A higher score means a higher severity of generalized anxiety disorder.
Measured: Day 1
Age-specific reference curves for the Patient Health Questionnaire (PHQ)9
Age-specific reference curves for the Patient Health Questionnaire (PHQ)9, a nine-item questionnaire with a total score ranging from 0-27. A total score of 10 or higher is suggestive of the presence of depression.
Measured: Day 1
Variables explaining differences between ageing in RA and population controls
Variables explaining differences between ageing in RA and population controls, such as age, disease duration, lifestyle factors and number of comorbidities
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Dec 2022
- Primary completion22 Apr 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zuyderland Medical Centre
- Responsible party
- Sponsor
- Investigators
- Marloes van Onna, Dr, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463666
- Sponsor's protocol ID
- NL71972.068.19
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Royston, P., & Wright, E. M. (1998). A Method for Estimating Age-Specific Reference Intervals ('Normal Ranges') Based on Fractional Polynomials and Exponential Transformation. Journal of the Royal Statistical Society. Series A (Statistics in Society), 161(1), 79-101. http://www.jstor.org/stable/2983555
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ageing on Interpretation of Disease Activity Measures and on Cognition, Physical Activity and Performance in Patients With Rheumatic Disorders
- ClinicalTrials.gov ID
- NCT05463666
- Acronym / sponsor ID
- NL71972.068.19
- Conditions
- Rheumatoid Arthritis
- Keywords
- ageing, elderly, reference curves, rheumatic disease, disease activity measures, cognitive function, physical activity, physical performance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Zuyderland Medical Centre
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Jul 2022 (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 primary objective of the STAR study is to investigate how measures of disease activity and measures for cognition, physical activity and performance behave in ageing population controls and patients with rheumatoid arthritis (RA). If an differential effect of age on outcome over time is apparent, the presence of an inclination point will be assessed. The secondary objective is to investigate additional factors (e.g. lifestyle factors) that might explain any differences between ageing controls and RA patients.
The STAR study is an observational cross-sectional matched case-control study including 420 RA patients and 420 population controls between 55-85 years of age, stratified by five year intervals. All participants will complete generic and RA-specific questionnaires. A subset of 180 participants will be visiting the research center for physical examination and performance tests. Expected outcomes include practical age-specific reference curves that will be constructed for a selection of outcomes (e.g. DAS28).
It is expected that as RA is characterized by tender and painful joints, e.g. the number of tender joints has a higher starting point in RA patients than in the general population. This will most likely increase in both groups with age, although the general population may catch up at an older age. Measures of cognitive status may show a steeper decline with age in RA patients compared to the general population. Measures of physical activity and performance will presumably have a worse starting point in RA patients than in the general population, and might show a steep decline with age. The general population might however catch up with the patients with RA. Most probably, age will not be the only factor explaining 'worse' outcomes in both RA patients and the general population. Other factors such as lifestyle factors (e.g. smoking, diet, BMI, occupation) and comorbidities will probably play a role.
Detailed description
Rationale:
As the population ages and the lifespan of people with rheumatoid arthritis (RA) extends, more insight into the effect of ageing on RA is needed. Currently, it is unclear whether ageing has an impact on the interpretation of disease activity measures, specifically the (components of the) DAS28. In addition, the effect of RA on cognitive function, physical activity and performance, three outcomes that will influence treatment decisions, is underinvestigated.
Objectives:
The objectives of this study are to gain insight into the effect of ageing on the result of disease activity measures, decline in cognition, physical activity and performance. A first step towards such understanding is construction of population reference curves in function of age. These curves can be used to discern whether the change in an outcome measure can be explained by age. If age is the only important factor, a similar change in the age-specific curve of both the population and RA patients would be observed. In case of differences in the curve inclination point, it is of interest exploring variables explaining such differences (e.g. lifestyle factors).
Study design:
Observational cross-sectional matched case-control study.
Study population:
In total, 420 RA patients and 420 population controls between 55 and 85 years of age, stratified according to age at five year intervals, will be included.
Main study parameters/endpoints:
A total of 840 participants will complete generic and RA-specific questionnaires. Out of these 840 participants, 180 (21%) will also visit the research center for a physical examination and performance tests. Reference curves will be constructed according to the method described by Wright and Royston for among others components of the DAS28. In case of a difference between population controls and RA patients, the investigators will further explore to gain insight which variables explain the difference.
Statistical analyses:
Total test scores will be computed for each questionnaire. Subsequently, descriptive statistics i.e. the mean, SD and range of each questionnaire will compared. Continuous determinants including biomarkers (e.g. ESR and CRP) will be presented as either mean with corresponding standard deviation for normally and median with corresponding inter-quartile range for non-normally distributed variables. Dichotomous determinants, including fulfillment of criteria, will be presented as N (%).
For the primary objective, reference curves will be developed by using data of the population controls by the method described by Wright and Royston (modelling variables as fractional polynomial functions of age). By including 70 patients per 5-year interval, reference curves can reliably be constructed. Reference curves will, if needed, be adjusted for comorbidity level and gender, when this adjustment improves substantially the fit of the data; otherwise, the model will be kept as simple as possible, which also contributes to their more feasible application in practice. The data from RA patients will be 'plotted' in population reference curves.
For the secondary objective, exploratory analyses of factors associated with ≥2 standard deviations (SD) (or Z-scores) change from the population average, will be performed for the outcomes of interest (disease activity measures, cognition, physical activity and performance). Univariate analysis is used for variable selection: logistic regression techniques (after checking assumptions) will be applied to test the association between age and other covariates (example: RA disease duration, lifestyle factors or differences in socio-economic background) on the outcomes (≥2 SD below reference value) of interest. A p-value below 0.05 is set to indicate a statistically significant difference. Next multivariable regression analyses will be performed with the same outcomes while forcing age into the models and further including all univariately significant covariates in a hierarchical approach (after checking co-linearity).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All participants need to complete generic and RA-specific questionnaires. Patients > 80 years who are physically unable to complete the whole study procedure (i.e. geriatric patients who are considered frail by the rheumatologist / researcher and/or patient itself), are allowed to undergo only part of the study measurements / questionnaires.
All 180 patients and controls will be seen in one study visit by 1-2 trained research assistant(s), using standardized protocols. Participants will undergo a physical examination, physical and laboratory (three blood samples; one venepuncture) testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population controls | – | –Participants between 55 and 85 years of age without a diagnosis of RA, or other inflammatory RMD (osteoarthritis allowed). Controls > 80 years who are physically unable to complete the whole study procedure, are allowed to undergo only part of the study measurements. |
| RA patients | – | Other: Rheumatoid arthritisParticipants between 55 and 85 years of age with a diagnosis of RA by the treating rheumatologist. Patients > 80 years who are physically unable to complete the whole study procedure, are allowed to undergo only part of the study measurements. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- RA patients for the STAR project will be recruited from the outpatient clinics of the MUMC and the Zuyderland Medical Center in Heerlen / Sittard by the rheumatologist. The control population will be recruited through friends and/or family members of patients and controls, snowball sampling; a qualified participant can share an invitation with other subjects similar to them, and recruitment via patient partners of the MUMC. Moreover, patients and controls will be recruited by giving a presentation about the study during a gathering of patients and their family at the Reumacafé, dissemination of flyers during regular information evening of the department of rheumatology at the MUMC and Zuyderland, and recruit via local social (sports) clubs.
Key inclusion criteria (4 listed)
- Age between 55-85 years at baseline.
- Diagnosis of RA by treating rheumatologist.
- Age between 55-85 years at baseline.
- No diagnosis of RA, or other inflammatory RMD (osteoarthritis allowed).
Key exclusion criteria (5 listed)
- Subject is the spouse/partner of the included RA patient.
- Have severe comorbidity and the treating rheumatologist and/or research team decides they should not be included in the study because of health reasons.
- A diagnosis of dementia or mental incompetency is always reason for exclusion.
- Persons of whom the research team estimates that his/her life expectancy is less than 2 years.
- Do not understand the Dutch language and/or are notable to understand the study information.
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 |
|---|---|---|
| Rheumatoid arthritisA diagnosis of rheumatoid arthritis. | Other | RA patients |
Primary outcome
Age-specific reference curve Disease Activity Score (DAS)28
Time frame: Day 1
Age-specific reference curve for components of the DAS28 (in subgroup). The DAS28 refers to 28 joints that examined in this assessment. Scores vary between 0-10, where higher DAS28 scores indicate a higher disease activity.
Age-specific reference curve Routine Assessment of Patient Index Data (RAPID)3 / Health Assessment Questionnaire (HAQ)2
Time frame: Day 1
Age-specific reference curve for question 3 and 6 of the RAPID3/Multidimensional HAQ2. The RAPID3 scores vary between 0-30, where higher scores indicate poorer status.
Age-specific reference curve Telephone Interview Cognitive Status (TICS)
Time frame: Day 1
Age-specific reference curve for the TICS. Total scores vary between 0-50, where a score below <34 or <28 may indicate a neurocognitive disorder as mild cognitive impairment (MCI) or dementia.
Age-specific reference curve Health Assessment Questionnaire (HAQ)
Time frame: Day 1
Age-specific reference curve for the HAQ. The HAQ is a questionnaire including 20 items in eight domains that measure difficulties in performing daily activities, where each question is rated on a scale from 0 to 3. A higher total score indicates higher disability in performing daily activities.
Age-specific reference curve timed stand chair test
Time frame: Day 1
Age-specific reference curve for the timed stand chair test (in subgroup).
5 secondary outcomes
Age-specific reference curves for the Fried criteria
Time frame: Day 1
Age-specific reference curves for the Groningen Frailty Indicator
Time frame: Day 1
Age-specific reference curves for the General Anxiety Disorder (GAD)7
Time frame: Day 1
Age-specific reference curves for the Patient Health Questionnaire (PHQ)9
Time frame: Day 1
Variables explaining differences between ageing in RA and population controls
Time frame: Day 1
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 1 Oct 2025.
- BackgroundRoyston, P., & Wright, E. M. (1998). A Method for Estimating Age-Specific Reference Intervals ('Normal Ranges') Based on Fractional Polynomials and Exponential Transformation. Journal of the Royal Statistical Society. Series A (Statistics in Society), 161(1), 79-101. http://www.jstor.org/stable/2983555
- 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.
Marloes van Onna, Dr principal investigator
Maastricht University Medical Center
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, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. 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 Netherlands. 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?
Age-specific reference curve Disease Activity Score (DAS)28 (time frame: Day 1). The study lists 5 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 NCT05463666, which also lists 1 linked publication.
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 1 Oct 2025.