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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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 Moisès 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 Sofía
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Anti-TNF
Drug: Anti-TNF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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