Rheumatoid ArthritisAROMANCT02804204
Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF
An observational study of Rheumatoid Arthritis, run by Hospital Universitari Vall d'Hebron Research Institute at 19 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Anti-TNF
- How many people
- 200 participants
- Where
- 19 sitesSpain
- Study dates
- Jun 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis according to the ACR criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
Sara Marsal, PhD contact
19 sites in 1 country
Spain19 sites, 19 recruiting
- Not yet recruiting
Complexo Hospitalaria A Coruña
A Coruña, Galicia
Francisco Javier Blanco
- Recruiting
Hospital Vall d'Hebron
Barcelona, Catalonia, 08028
Sara Marsal, PhD
- Not yet recruiting
Clínic de Barcelona
Barcelona, Catalonia
Raimon Sanmartí
- Not yet recruiting
Hospital de Santa Creu i Sant Pau
Barcelona, Catalonia
Josep María Llobet
- Not yet recruiting
Hospital de Basurto
Bilbao, Basque Country
María Luz García
- Not yet recruiting
Hospital San Cecilio
Granada, Andalusia
Enrique Raya
- Not yet recruiting
Hospital de Guadalajara
Guadalajara, Castille-La Mancha
Jesús Tornero
- Not yet recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, Catalonia
Joan Maymó
- Not yet recruiting
Hospital Clínico San Carlos
Madrid, Madrid
Ricardo Blanco
- Not yet recruiting
Hospital Infanta Sofía
Madrid, Madrid
Santiago Muñoz
- Not yet recruiting
Hospital La Paz
Madrid, Madrid
Alejandro Balsa
- Not yet recruiting
Hospital Puerta de Hierro
Madrid, Madrid
Jose Luis Andreu
- Not yet recruiting
Hospital Carlos Haya
Málaga, Andalusia
Antonio Fernandez Nebro
- Not yet recruiting
Hospital Virgen de la Arreixaca
Murcia, Murcia
Javier Martínez
- Not yet recruiting
Hospital Son LLatzer
Palma de Mallorca, Balearic Islands
Antonio Juan Mas
- Not yet recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Canary Islands
Federico Díaz
- Not yet recruiting
Hospital Moises Broggi
Sant Joan Despí, Catalonia
Hector Corominas
- Not yet recruiting
Hospital Marques de Valdecilla
Santander, Cantabria
Ricardo Blanco
- Not yet recruiting
Hospital Virgen del Rocio
Seville, Andalusia
Juan Povedano
About this study
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
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
- Rheumatoid Arthritis
- Being tested
- Anti-TNF
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNFDrug
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF | Not described Receives: Drug: Anti-TNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-TNF treatment response based on circulant rheumatoid factor
Measured: 24 weeks
Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804204
- Sponsor's protocol ID
- SMB-CZP- 2014-03
- Acronym
- AROMA
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02804204
- Acronym / sponsor ID
- AROMA / SMB-CZP- 2014-03
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF | – | Drug: Anti-TNF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis according to the ACR criteria
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-TNF | Drug | Anti-TNF |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Marsal, PhD contact
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hospital Universitari Vall d'Hebron Research Institute at 19 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Marsal, PhD (+34 93 402 90 82), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-TNF treatment response based on circulant rheumatoid factor (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.