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

Rheumatoid Arthritis Clinical Trial

— AROMA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804204
• Other study ID #: SMB-CZP- 2014-03
• Status: Recruiting
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Sara Marsal, PhD
• Phone: +34 93 402 90 82
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Anti-TNF

Locations

Country	Name	City	State
Spain	Complexo Hospitalaria A Coruña	A Coruña	Galicia
Spain	Clínic de Barcelona	Barcelona	Catalunya
Spain	Hospital de Santa Creu i Sant Pau	Barcelona	Catalunya
Spain	Hospital Vall d'Hebron	Barcelona	Catalunya
Spain	Hospital de Basurto	Bilbao	Pais Vasco
Spain	Hospital San Cecilio	Granada	Andalucia
Spain	Hospital de Guadalajara	Guadalajara	Castilla-La Mancha
Spain	Hospital de Bellvitge	L'Hospitalet de Llobregat	Catalunya
Spain	Hospital Universitario de Canarias	La Laguna	Canarias
Spain	Hospital Clínico San Carlos	Madrid	Comunidad De Madrid
Spain	Hospital Infanta Sofía	Madrid	Comunidad De Madrid
Spain	Hospital La Paz	Madrid	Comunidad De Madrid
Spain	Hospital Puerta de Hierro	Madrid	Comunidad De Madrid
Spain	Hospital Carlos Haya	Málaga	Andalucia
Spain	Hospital Virgen de la Arreixaca	Murcia	Región De Murcia
Spain	Hospital Son LLatzer	Palma de Mallorca	Baleares
Spain	Hospital Moises Broggi	Sant Joan Despí	Catalunya
Spain	Hospital Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Virgen del Rocio	Sevilla	Andalucia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	UCB Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-TNF treatment response based on circulant rheumatoid factor		24 weeks
Primary	Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.		24 weeks