Rheumatoid Arthritis
Conditions
Interventions
Group 1: In this observational study of moderate to severe, active RA patients, after intensification of anti-inflammatory treatment,
1. Determine proportion of RA patients with severe persisting pa
Sponsors
AbbVie Deutschland GmbH Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Adult patients with a confirmed diagnosis of rheumatoid arthritis according to American College of Rheumatology (ACR) 2010 criteria with active disease (DAS28 = 3.2) plus SJC > 3, CRP above the upper limit of normal or normal CRP value and planned initiation or escalation of anti-inflammatory Treatment - Disease duration (RA) = 8 years - Severe Pain (VAS (0-100) = 50)) - Patients with the intellectual capacity to take part in this study - Adult patients whose signed written informed consent has been obtained
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Patients with a history of chronically manifested pain due to degenerative joint disease, previous surgery, myofascial or ligament dysfunction preceding the flare (active disease inclusion criterion) - Patients with Fibromyalgia syndrome - Patients with diabetic neuropathy - Patients with Psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with severe, persisting pain Visual analogue scale(VAS (0-100) = 50) after week 12 and week 24 despite Disease Activity Score 28 (DAS28) response | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Identification of risk factors for severe, persisting pain and their predictive value at baseline and week 24 for outcome at week 24 and week 48 respectively, determined by multivariable modeling: - Disease Activity Score 28 (DAS28) - DAS28 single components (Tender Joint Count (TJC), Swollen Joint Count (SJC), Patient Global disease Activity (PGA), Erythrocyte sedimentation rate(ESR)/C-reactive Protein (CRP)) - Seropositivity (anti citrullinated protein antibodies (ACPA) and/or Rheumatoid factor (RF) positive) - Patient-reported outcomes (PRO)s: VAS pain, Rheuma-Schmerz, painDetect, RAID, HAQ, PCS GE and PHQ 9 questionnaires - Concommittant pain medication (dummy coded) Diagnostic validity (sensitivity and specificity) of these factors and their combination will be modelled as described. 3. Effectiveness of early pain-management (Case-control design): Proportion (%) of patients achieving a reduction in pain intensity of VAS = 30% (representing a clinical relevant pain relief) at week 48 with and without multimodal pain management | — |
Countries
Germany
Contacts
Public ContactEdgar Stemmler
AbbVie Deutschland GmbH & Co. KG
Outcome results
None listed