Difficult-to-treat RA: a study to obtain insight into the occurrence and nature of potential problems underlying the disease state and into its clinical burden

Difficult-to-treat RA: a study to obtain insight into the occurrence and nature of potential problems underlying the disease state and into its clinical burden - D2T RA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49002

Enrollment

300

Registered

2018-12-19

Start date

2019-02-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis RA

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age * 18 years * Patient can speak and read Dutch * Fulfilling 2010 American College of Rheumatology (ACR)/EULAR classification criteria for RA * Treatment according to the current standard of care/EULAR recommendations for at least one year, Additional criteria for difficult-to-treat RA group: * Failure of *2 b/tsDMARDs (with different mechanism of action) after failing csDMARD therapy (unless contraindicated) * Signs of active/progressive disease, defined as *1 of: o At least moderate disease activity (according to validated composite measures including joint counts e.g. DAS28-ESR > 3.2 or CDAI >10) o Signs (including inflammatory markers and imaging) and/or symptoms suggestive of active disease (joint related or other) o Rapid radiographic progression (with or without signs of active disease) o Inability to taper glucocorticoid treatment (below 7.5 mg/day prednisone or equivalent) o Well-controlled disease according to above standards, but still having RA symptoms that are causing a reduction in Quality of Life * The management of signs and/or symptoms is perceived as problematic by the rheumatologist and/or the patient. , Additional criteria for control group: * not fulfilling the definition of difficult-to-treat RA.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
- Clinical RA activity - Objectively assessed inflammation - Potential problems underlying difficult-to-treat RA: * Causes of persistent inflammation * Non-inflammatory causes of complaints * Factors which hamper proper grading Sub study: Qualitative research about non-adherence to DMARDs - Reasons for being (non-)adherent: Gathered through face-to-face interviews and thereafter sorted using a card sorting task - Facilitators and barriers of treatment adherence: Gathered through face-to-face interviews and thereafter sorted using a card sorting task - Differences between patients and rheumatologists regarding the level of applicability of reasons, facilitators and barriers to themselves and the general population of RA patients, respectively	—

Measure

Time frame

- Clinical RA activity - Objectively assessed inflammation - Potential problems underlying difficult-to-treat RA: * Causes of persistent inflammation * Non-inflammatory causes of complaints * Factors which hamper proper grading Sub study: Qualitative research about non-adherence to DMARDs - Reasons for being (non-)adherent: Gathered through face-to-face interviews and thereafter sorted using a card sorting task - Facilitators and barriers of treatment adherence: Gathered through face-to-face interviews and thereafter sorted using a card sorting task - Differences between patients and rheumatologists regarding the level of applicability of reasons, facilitators and barriers to themselves and the general population of RA patients, respectively

—

Secondary

Measure	Time frame
Clinical burden: - Patient burden: * Quality of Life using EuroQol 5 dimensions (EQ-5D) * Functional ability using Health assessment questionnaire (HAQ) - Socioeconomic burden: Health care utilization and work participation costs Serum biomarkers levels: - Serum biomarker levels, including but not limited to IL-6	—

Countries

Netherlands

Outcome results