NCT02804204UnknownNot Applicable
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
Hospital Universitari Vall d'Hebron Research Institute19 sites in 1 country200 target enrollmentStarted: June 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 200
- Locations
- 19
- Primary Endpoint
- Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Anti-TNF
Intervention: Anti-TNF (Drug)
Outcomes
Primary Outcomes
Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.
Time Frame: 24 weeks
Anti-TNF treatment response based on circulant rheumatoid factor
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (19)
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