Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.

Phase 1

• Conditions: Rheumatic diseases; MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000005156; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-004173-32-DK
• Lead Sponsor: Department of Clinical Biochemestry, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-20
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

- Patientes in treatment with one of the 3 IMPs due to a rheumatoid disease for minimum 3 months
- age 18 or more.
- Informed consent has been signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

- Any malignancy
- Known pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified