Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Anti-TNF
- Registration Number
- NCT02804204
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anti-TNF Anti-TNF -
- Primary Outcome Measures
Name Time Method Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies. 24 weeks Anti-TNF treatment response based on circulant rheumatoid factor 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Hospital Virgen del Rocio
🇪🇸Sevilla, Andalucia, Spain
Clínic de Barcelona
🇪🇸Barcelona, Catalunya, Spain
Hospital de Basurto
🇪🇸Bilbao, Pais Vasco, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Comunidad De Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Comunidad De Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Comunidad De Madrid, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Canarias, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Catalunya, Spain
Hospital Virgen de la Arreixaca
🇪🇸Murcia, Región De Murcia, Spain
Hospital de Santa Creu i Sant Pau
🇪🇸Barcelona, Catalunya, Spain
Hospital Carlos Haya
🇪🇸Málaga, Andalucia, Spain
Hospital San Cecilio
🇪🇸Granada, Andalucia, Spain
Hospital de Guadalajara
🇪🇸Guadalajara, Castilla-La Mancha, Spain
Hospital Son LLatzer
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital Moises Broggi
🇪🇸Sant Joan Despí, Catalunya, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Catalunya, Spain
Hospital Infanta Sofía
🇪🇸Madrid, Comunidad De Madrid, Spain
Complexo Hospitalaria A Coruña
🇪🇸A Coruña, Galicia, Spain