Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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. |
From baseline to 5 years followup |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
| Secondary |
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 at baseline |
|
