Inflammatory ArthritisNCT06402396
Assessing Pain by the painDETECT Questionnaire (PDQ)
An observational study of Inflammatory Arthritis and Spondylarthropathies, run by University Hospital Bispebjerg and Frederiksberg.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Spondylarthropathies, Rheumatoid Arthritis
- What is being tested?
- bDMARDS
- How many people
- 7,056 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to 1 Jan 2027
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Missing answer to PDQ
About this study
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
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)
Read the 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.
- Being tested
- bDMARDS
- Keywords
- Drug survival, Pain phenotypes, PainDETECT Questionnaire, Inflammatory Arthritis
- Medical subject headings
- Arthritis, Spondylarthropathies, Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bDMARDSDrug
Patients at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.
| Study group | Role | What they receive |
|---|---|---|
| Non-Neuropathic pain phenotype | Based on the PainDETECT Questionnaire (PDQ), patients scoring <13 will be classified as "exposed" as they are considered a group with non-neuropathic pain (Non-neuropathic pain phenotype) Receives: Drug: bDMARDS | |
| Neuropathic pain phenotype | Based on the PainDETECT Questionnaire (PDQ), patients scoring ≥13 will be classified as "un-exposed" as they are considered a group with neuropathic pain (neuropathic pain phenotype) Receives: Drug: bDMARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in bDMARDs drug retention rates
Drug retention rates will be described using Kapan-Mayer curves. Differences in changes in bDMARDs drug retention rates over 5 years between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Secondary outcomes (23)
Differences in Patient acceptable symptom state (Pass)
Differences in changes in patients having an acceptable symptom state at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
The PASS is defined as the highest symptom level below which a patient considers his/her symptom state as acceptable. it is answered via a yes or a no.
Measured: From baseline to 5 years followup
Differences in Swollen Joint Count (SJC, 0-28)
Differences in changes in SJC 0-28 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Differences in TenderJoint Count (TJC, 0-28)
Differences in changes in TJC 0-28 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Differences in Doctors' global assessment (VAS 0-100 mm.)
Differences in changes in Doctors' global assessment 0-100 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Differences in VAS pain (0-100 mm) (Higher indicates more pain)
Differences in changes in VAS pain (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Differences in VAS fatigue (0-100 mm) (Higher indicates more fatigue)
Differences in changes in VAS fatigue (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Differences in VAS global (0-100 mm) (Higher indicates more global disease activity)
Differences in changes in VAS global (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
Differences in HAQ (0-3) (higher indicates a more impaired functional level)
Differences in changes in HAQ (0-3) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire. 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided by 8. The result is the DI disability index index. In the event that one section is not completed by a subject then the summed score would be divided by 7.
Measured: From baseline to 5 years followup
Differences in CRP (mg/L)
Differences in changes in CRP (mg/L) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Measured: From baseline to 5 years followup
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on RA diagnosis.
The probability of having an RA diagnosis when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PsA diagnosis.
The probability of having an PsA diagnosis when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on SpA diagnosis.
The probability of having an SpA diagnosis when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on number of bioswitches.
The probability of having bioswitches when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Swollen Joint Count (SJC, 0-28)
The probability of having less swollen joints on the SJC 0-28 when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on TenderJoint Count (TJC, 0-28)
The probability of having less tender joints on the TJC 0-28 when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Doctors' global assessment (VAS: 0-100 mm)
The probability of having a favourable score on Doctors' global assessment (VAS: 0-100 mm) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PASS (y/n)
The probability of having an acceptable symptom state (PASS) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Patient acceptable symptom score (PASS (y/n))
The probability of having a favourable score on Patient acceptable symptom score (PASS) (yes/no) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS pain (0-100 mm)
The probability of having a favourable score on VAS pain (0-100 mm) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS fatigue (0-100 mm)
The probability of having a favourable score on VAS fatigue (0-100 mm) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS global (0-100 mm)
The probability of having a favourable score on VAS global (0-100 mm) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on the Health assessment questionnaire (HAQ (0-3))
The probability of having a favourable score on HAQ (0-3 mm) when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on C- reactive protein (CRP (mg/L))
The probability of having a favourable CRP when having a non-neuropathic pain phenotype.
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study startJan 2013
- Primary completion1 Dec 2019
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,056 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Ginnerup-Nielsen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Kirstine Amris, MD, DMSc, Study chair, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402396
- Sponsor's protocol ID
- DANBIO PDQ
- Status last verified
- May 2025
- First submitted
- 2 May 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to data can be granted upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06402396
- Acronym / sponsor ID
- DANBIO PDQ
- Keywords
- Drug survival, Pain phenotypes, PainDETECT Questionnaire, Inflammatory Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,056 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 May 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Neuropathic pain phenotype | – | Drug: bDMARDSBased on the PainDETECT Questionnaire (PDQ), patients scoring <13 will be classified as "exposed" as they are considered a group with non-neuropathic pain (Non-neuropathic pain phenotype) |
| Neuropathic pain phenotype | – | Drug: bDMARDSBased on the PainDETECT Questionnaire (PDQ), patients scoring ≥13 will be classified as "un-exposed" as they are considered a group with neuropathic pain (neuropathic pain phenotype) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Missing answer to PDQ
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 |
|---|---|---|
| bDMARDSPatients at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment. | Drug | Neuropathic pain phenotype, Non-Neuropathic pain phenotype |
Primary outcome
Differences in bDMARDs drug retention rates
Time frame: From baseline to 5 years followup
Drug retention rates will be described using Kapan-Mayer curves. Differences in changes in bDMARDs drug retention rates over 5 years between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
23 secondary outcomes
Differences in Patient acceptable symptom state (Pass)
Time frame: From baseline to 5 years followup
Differences in Swollen Joint Count (SJC, 0-28)
Time frame: From baseline to 5 years followup
Differences in TenderJoint Count (TJC, 0-28)
Time frame: From baseline to 5 years followup
Differences in Doctors' global assessment (VAS 0-100 mm.)
Time frame: From baseline to 5 years followup
Differences in VAS pain (0-100 mm) (Higher indicates more pain)
Time frame: From baseline to 5 years followup
Differences in VAS fatigue (0-100 mm) (Higher indicates more fatigue)
Time frame: From baseline to 5 years followup
Differences in VAS global (0-100 mm) (Higher indicates more global disease activity)
Time frame: From baseline to 5 years followup
Differences in HAQ (0-3) (higher indicates a more impaired functional level)
Time frame: From baseline to 5 years followup
Differences in CRP (mg/L)
Time frame: From baseline to 5 years followup
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on RA diagnosis.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PsA diagnosis.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on SpA diagnosis.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on number of bioswitches.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Swollen Joint Count (SJC, 0-28)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on TenderJoint Count (TJC, 0-28)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Doctors' global assessment (VAS: 0-100 mm)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PASS (y/n)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Patient acceptable symptom score (PASS (y/n))
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS pain (0-100 mm)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS fatigue (0-100 mm)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS global (0-100 mm)
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on the Health assessment questionnaire (HAQ (0-3))
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on C- reactive protein (CRP (mg/L))
Time frame: Measured at baseline
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 20 May 2025.
- Individual participant dataSharing planned: No. Access to data can be granted upon reasonable request
Related trials for Inflammatory Arthritis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Recruiting
Shock Waves in Knee Arthritis
Arthritis of Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
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.
Kirstine Amris, MD, DMSc study chair
Bispebjerg and Frederiksberg Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Arthritis and Spondylarthropathies, run by University Hospital Bispebjerg and Frederiksberg.
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 3 inclusion and 1 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Differences in bDMARDs drug retention rates (time frame: From baseline to 5 years followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.