Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborator: UCB Pharma

Criteria

Inclusion Criteria:

• Both genders

• Over 18 years old

• Diagnosis of rheumatoid arthritis according to ACR criteria

• Patients that initiate treatment with anti-TNF drugs according to clinical practice, both in naïve anti-TNF patients and patients after first anti-TNF failure

• Patients able to follow the protocol requirements

• Patients that signed the informed consent

Exclusion Criteria:

• Patients with known hypersensitivity to investigational products

• Patients with tuberculosis, or severe infections like sepsis or opportunistic infections

• Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV)

• Patients that according to the investigator criteria can not participate in the study or complete the study questionnaires

• Pregnant or fertile woman that does not use a contraception method