Status unknownNCT02804204AROMAUpdated Feb 7, 2019

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

An observational study in Rheumatoid Arthritis, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 19 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Rheumatoid Arthritis

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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 200 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

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Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Patients with rheumatoid arthritis according to the ACR criteria

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

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

Observational model: Case-only
Time perspective: Prospective
Enrollment: 200 participants (estimated)
Patient registry: No

Groups and cohorts

Anti-TNF
Drug: Anti-TNF

Interventions

DrugAnti-TNF

What researchers measure

Primary outcomes

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

Study locations

1 of 19 sites recruiting

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02804204
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: UCB Pharma
Responsible party: Sponsor
First posted: Jun 17, 2016
Start date: Jun 2016
Primary completion: Dec 2019 (estimated)
Completion: Dec 2019 (estimated)
Last update: Feb 7, 2019

Study contacts

Sara Marsal, PhD

Contact

+34 93 402 90 82

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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