Clinical trial NCT02804204: Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF
Official title: Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2016-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis according to the ACR criteria

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.


Eligibility 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

Primary outcomes:
measure: Anti-TNF treatment response based on circulant rheumatoid factor
timeFrame: 24 weeks
measure: Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital San Cecilio
state: Andalucia
city: Málaga
country: Spain
facility: Hospital Carlos Haya
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
state: Andalucia
city: Palma de Mallorca
country: Spain
facility: Hospital Son LLatzer
state: Baleares
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
state: Cantabria
city: Guadalajara
country: Spain
facility: Hospital de Guadalajara
state: Castilla-La Mancha
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Catalunya
city: Barcelona
country: Spain
facility: Clínic de Barcelona
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital de Santa Creu i Sant Pau
state: Catalunya
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Catalunya
city: Sant Joan Despí
country: Spain
facility: Hospital Moises Broggi
state: Catalunya
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Infanta Sofía
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital La Paz
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
state: Comunidad De Madrid
city: A Coruña
country: Spain
facility: Complexo Hospitalaria A Coruña
state: Galicia
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Pais Vasco
city: Murcia
country: Spain
facility: Hospital Virgen de la Arreixaca
state: Región De Murcia
Study officials:
References: