Individualised therapy of rheumatoid arthritis with anti-tumour necrosis factor (TNF) antibodies (adalimuab) based on neuroendocrine biomarkers, a prospective clinical study

niversity Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)0 sites60 target enrollmentSeptember 30, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
Enrollment: 60
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

September 30, 2008

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)

•1\. Rheumatoid arthritis (RA) is diagnosed according to the American College of Rheumatology criteria
•2\. Both males and females, age must be 18 years or older
•3\. Patients must have given written informed consent
•4\. The disease duration should be less than 24 months
•5\. The DAS28 score must be above 5\.0
•6\. The number of swollen joints must be \>\=8
•7\. The number of tender joints must be \>\=10
•8\. The erythrocyte sedimentation rate must be \>\=28 mm/hour

•1\. Other inflammatory arthropathies such as psoriasis arthritis and similar conditions
•2\. Treatment with disease modifying anti\-rheumatic drugs (DMARDs), glucocorticoids, or biologics
•3\. Severe or uncontrolled co?morbidities (e.g. infectious, metabolic, hepatic, cardiac, malignant, psychiatric co?morbidities)
•4\. A positive screening test result for tuberculosis (purified protein of tuberculin 5 \[PPD5] test, chest radiography). Patients at high risk for tuberculosis are excluded or are treated with isoniazid up to 300 mg/day concomitantly.
•5\. Patients of child\-bearing potential without adequate contraceptive protection
•6\. Patients with contraindications for trial drugs