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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009749

Enrollment

Registered

2016-01-18

Start date

2016-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M05 M06

Interventions

Group 1: Thirty patients with active rheumatoid arthritis and EULAR guideline based therapy decision for change of medication from synthetic disease modifying drugs (SDMARD) to TNF-alpha inhibiting, b

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Germany

Contacts

Public ContactPhilipp Baumbach

Klinik für Anästhesiologie und Intensivmedizin | Universitätsklinikum Jena

Philipp.Baumbach@med.uni-jena.de+49-3641-9-325798

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026