Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF
AROMA
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
1 other identifier
observational
200
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 7, 2019
June 1, 2016
3.5 years
June 8, 2016
February 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Anti-TNF treatment response based on circulant rheumatoid factor
24 weeks
Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.
24 weeks
Study Arms (1)
Anti-TNF
Interventions
Eligibility Criteria
Patients with rheumatoid arthritis according to the ACR criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari Vall d'Hebron Research Institutelead
- UCB Pharmacollaborator
Study Sites (19)
Hospital San Cecilio
Granada, Andalusia, Spain
Hospital Carlos Haya
Málaga, Andalusia, Spain
Hospital Virgen del Rocio
Seville, Andalusia, Spain
Hospital Son LLatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital de Basurto
Bilbao, Basque Country, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Canary Islands, Spain
Hospital Marques de Valdecilla
Santander, Cantabria, Spain
Hospital de Guadalajara
Guadalajara, Castille-La Mancha, Spain
Hospital Vall d'Hebron
Barcelona, Catalonia, 08028, Spain
Clínic de Barcelona
Barcelona, Catalonia, Spain
Hospital de Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Moises Broggi
Sant Joan Despí, Catalonia, Spain
Complexo Hospitalaria A Coruña
A Coruña, Galicia, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Infanta Sofía
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Puerta de Hierro
Madrid, Madrid, Spain
Hospital Virgen de la Arreixaca
Murcia, Murcia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 17, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 7, 2019
Record last verified: 2016-06