Early effects of TNF-alpha blocking on pain scores and quantitative sensory testing in patients with active rheumatoid arthritis

• Conditions: M05; M06; Seropositive rheumatoid arthritis; Other rheumatoid arthritis

• Registration Number: DRKS00009749
• Lead Sponsor: Funktionsbereich Rheumatologie | Klinik für Innere Medizin III | Universitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(1) diagnosis rheumatoid arthritis (2010 ACR criteria)
(2) active rheumatoid arthritis (DAS>=2.6)
(3) physicians decision (in accordance with EULAR guidelines) to initiate methotrexate treatment or to change treatment from synthetic disease modifying drug (sDMARD) to TNF-alpha-blocking biologic DMARD (Infliximab, Etanercept, Adalimumab, Certolizumab or Golimumab)
(4) written informed consent

Exclusion Criteria

(1) non-rheumatoid arthritis associated neuropathies and/or polyneuropathies (including diabetic neuropathy)
(2) severe neurological disease (e.g. apoplex, morbus parkinson)
(3) acute psychiatric disease requiring treatment (e.g. depression, schizophrenia)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain reduction of pain intensities (numeric rating scales) and pain interference (Pain disability Index) as well as changes in QST parameters (5d, 4w and 12w) after initiation of TNF-alpha inhibition or Methotrexat therapy compared to baseline values.

Secondary Outcome Measures

Name	Time	Method
According changes (identical timepoints, see above) in disease activity scores for rheumatoid arthritis (DAS28), serological inflammation markers (c-reactive protein, erythrocyte sedimentation rate), serum levels of selected proinflammatory cytokines (TNF-alpha, IL-1, IL-1Ra, IL-6, IL-17, IL-21, IL-23), hand function assessment, RA induced interference (Health Assessment Questionnaire) and health related quality of life (SF-36).