Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGAnti-TNF
Sponsors
UCB Pharma
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-TNF treatment response based on circulant rheumatoid factor | 24 weeks |
| Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies. | 24 weeks |
Countries
Spain
Contacts
Primary ContactSara Marsal, PhD
Outcome results
None listed