Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF (AROMA)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Drug: Anti-TNF

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02804204

SMB-CZP- 2014-03

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Anti-TNF

Treatment:

Drug: Anti-TNF