Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Anti-TNF

• Registration Number: NCT02804204
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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

Trial Locations

Locations (19)

Hospital San Cecilio; 🇪🇸 Granada, Andalucia, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Andalucia, Spain

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Andalucia, Spain

Hospital Son LLatzer; 🇪🇸 Palma de Mallorca, Baleares, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Canarias, Spain

Hospital Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital de Guadalajara; 🇪🇸 Guadalajara, Castilla-La Mancha, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Catalunya, Spain

Clínic de Barcelona; 🇪🇸 Barcelona, Catalunya, Spain

Hospital de Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalunya, Spain

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