Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF (AROMA)

February 6, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sara Marsal, PhD
  • Phone Number: +34 93 402 90 82

Study Locations

  • Spain
    • Andalucia
      • Granada, Andalucia, Spain
        • Not yet recruiting
        • Hospital San Cecilio
        • Contact:
          • Enrique Raya
      • Málaga, Andalucia, Spain
        • Not yet recruiting
        • Hospital Carlos Haya
        • Contact:
          • Antonio Fernandez Nebro
      • Sevilla, Andalucia, Spain
        • Not yet recruiting
        • Hospital Virgen del Rocío
        • Contact:
          • Juan Povedano
    • Baleares
      • Palma de Mallorca, Baleares, Spain
        • Not yet recruiting
        • Hospital Son Llatzer
        • Contact:
          • Antonio Juan Mas
    • Canarias
      • La Laguna, Canarias, Spain
        • Not yet recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • Federico Díaz
    • Cantabria
      • Santander, Cantabria, Spain
        • Not yet recruiting
        • Hospital Marqués de Valdecilla
        • Contact:
          • Ricardo Blanco
    • Castilla-La Mancha
      • Guadalajara, Castilla-La Mancha, Spain
        • Not yet recruiting
        • Hospital de Guadalajara
        • Contact:
          • Jesús Tornero
    • Catalunya
      • Barcelona, Catalunya, Spain, 08028
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
          • Sara Marsal, PhD
      • Barcelona, Catalunya, Spain
        • Not yet recruiting
        • Clinic de Barcelona
        • Contact:
          • Raimón Sanmartí
      • Barcelona, Catalunya, Spain
        • Not yet recruiting
        • Hospital de Santa Creu I Sant Pau
        • Contact:
          • Josep María Llobet
      • L'Hospitalet de Llobregat, Catalunya, Spain
        • Not yet recruiting
        • Hospital de Bellvitge
        • Contact:
          • Joan Maymó
      • Sant Joan Despí, Catalunya, Spain
        • Not yet recruiting
        • Hospital Moisés Broggi
        • Contact:
          • Hector Corominas
    • Comunidad De Madrid
      • Madrid, Comunidad De Madrid, Spain
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Ricardo Blanco
      • Madrid, Comunidad De Madrid, Spain
        • Not yet recruiting
        • Hospital Infanta Sofia
        • Contact:
          • Santiago Muñoz
      • Madrid, Comunidad De Madrid, Spain
        • Not yet recruiting
        • Hospital La Paz
        • Contact:
          • Alejandro Balsa
      • Madrid, Comunidad De Madrid, Spain
        • Not yet recruiting
        • Hospital Puerta de Hierro
        • Contact:
          • Jose Luis Andreu
    • Galicia
      • A Coruña, Galicia, Spain
        • Not yet recruiting
        • Complexo Hospitalaria A Coruña
        • Contact:
          • Francisco Javier Blanco
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain
        • Not yet recruiting
        • Hospital De Basurto
        • Contact:
          • María Luz García
    • Región De Murcia
      • Murcia, Región De Murcia, Spain
        • Not yet recruiting
        • Hospital Virgen de la Arreixaca
        • Contact:
          • Javier Martínez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rheumatoid arthritis according to the ACR criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anti-TNF
Drug: Anti-TNF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-TNF treatment response based on circulant rheumatoid factor
Time Frame: 24 weeks
24 weeks
Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMB-CZP- 2014-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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