Clinical trial NCT06402396: Assessing Pain by the painDETECT Questionnaire (PDQ)
Official title: Assessing Pain by the painDETECT Questionnaire (PDQ) to Evaluate Drug Retention in Patients With Inflammatory Arthritis: A Danish Nationwide Prospective DANBIO Registry Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Arthritis
Spondylarthropathies
Rheumatoid Arthritis
Psoriatic Arthritis
Keywords: Drug survival
Pain phenotypes
PainDETECT Questionnaire
Inflammatory Arthritis
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 7056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Patients registered in DANBIO, having inflammatory arthritis (Specific diagnoses include RA, PsA and other SpA) and at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

Brief summary: Prospective cohort study using drug survival rates to assess the predictive value of the PDQ when used to classify patients into a non-neuropathic pain phenotype group (score \<13) or a neuropathic pain phenotype group (score ≥13)

Detailed description: The original painDETECT questionnaire (PDQ) DANBIO study was a survey among all DANBIO users having an arthritis diagnosis 'Pain and pain mechanisms in patients with inflammatory arthritis: A Danish nationwide cross-sectional DANBIO registry survey'. The PDQ was implemented onto the DANBIO touch screens for a period of 6 months in 2013-14 and data from more than 7000 individual patients were collected. The overall background for the study was that central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The study showed that approximately 50 % of patients experienced significant pain levels and that a high PDQ score was associated with higher levels of pain and DAS28 but not with markers of inflammatory activity such as CRP and swollen joint count. Furthermore, indications of more frequent bio-switch in the PDQ groups showing neuropathic pain features were found.

The aim of this study is to examine the association between drug retention of biological DMARDs (bDMARDs) and the PDQ pain classification categories (i.e. non-neuropathic vs. neuropathic features) and to investigate whether this categorization is predictive of drug retention and changes in clinical outcomes over a 5-year period.

Eligibility criteria: Inclusion Criteria:

* Registered in DANBIO
* Having inflammatory arthritis (Specific diagnoses include RA, PsA and other SpA)
* At time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

Exclusion Criteria:

- Missing answer to PDQ

Primary outcomes:
measure: Differences in bDMARDs drug retention rates
timeFrame: From baseline to 5 years followup
Secondary outcomes:
measure: Differences in Patient acceptable symptom state (Pass)
timeFrame: From baseline to 5 years followup
measure: Differences in Swollen Joint Count (SJC, 0-28)
timeFrame: From baseline to 5 years followup
measure: Differences in TenderJoint Count (TJC, 0-28)
timeFrame: From baseline to 5 years followup
measure: Differences in Doctors' global assessment (VAS 0-100 mm.)
timeFrame: From baseline to 5 years followup
measure: Differences in VAS pain (0-100 mm) (Higher indicates more pain)
timeFrame: From baseline to 5 years followup
measure: Differences in VAS fatigue (0-100 mm) (Higher indicates more fatigue)
timeFrame: From baseline to 5 years followup
measure: Differences in VAS global (0-100 mm) (Higher indicates more global disease activity)
timeFrame: From baseline to 5 years followup
measure: Differences in HAQ (0-3) (higher indicates a more impaired functional level)
timeFrame: From baseline to 5 years followup
measure: Differences in CRP (mg/L)
timeFrame: From baseline to 5 years followup
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on RA diagnosis.
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PsA diagnosis.
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on SpA diagnosis.
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on number of bioswitches.
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Swollen Joint Count (SJC, 0-28)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on TenderJoint Count (TJC, 0-28)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Doctors' global assessment (VAS: 0-100 mm)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PASS (y/n)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Patient acceptable symptom score (PASS (y/n))
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS pain (0-100 mm)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS fatigue (0-100 mm)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS global (0-100 mm)
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on the Health assessment questionnaire (HAQ (0-3))
timeFrame: Measured at baseline
measure: The prognostic value of pain phenotype classification by PainDETECT (PDQ) on C- reactive protein (CRP (mg/L))
timeFrame: Measured at baseline
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital
name: Kirstine Amris, MD, DMSc
role: STUDY_CHAIR
References: