STudying Ageing in Rheumatic Diseases (STAR)

NCT05463666 | Active Not Recruiting DMC

• 1 other identifier: NL71972.068.19
• Study Type: observational
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Rheumatoid Arthritis

Keywords

ageing; elderly; reference curves; rheumatic disease; disease activity measures; cognitive function; physical activity; physical performance; treatment

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  Day 1

• Age-specific reference curve timed stand chair test

  Age-specific reference curve for the timed stand chair test (in subgroup).

  Day 1

Secondary Outcomes (5)

• Age-specific reference curves for the Fried criteria

  Day 1

• Age-specific reference curves for the Groningen Frailty Indicator

  Day 1

• Age-specific reference curves for the General Anxiety Disorder (GAD)7

  Day 1

• Age-specific reference curves for the Patient Health Questionnaire (PHQ)9

  Day 1

• Variables explaining differences between ageing in RA and population controls

  Day 1

Study Arms (2)

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.

Other: Rheumatoid arthritis

Interventions

Rheumatoid arthritis OTHER

A diagnosis of rheumatoid arthritis.

RA patients

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Zuyderland Medical Centre: collaborator

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Determination of ESR, CRP and stored serum.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Rheumatic Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Marloes van Onna, Dr

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 19, 2022
• Study Start: December 1, 2022
• Primary Completion: April 22, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)