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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02804204
Collaborator
UCB Pharma (Industry)
200
Enrollment
19
Locations
42
Duration (Months)
10.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Anti-TNF

Drug: Anti-TNF

Outcome Measures

Primary Outcome Measures

  1. Anti-TNF treatment response based on circulant rheumatoid factor [24 weeks]

  2. Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital San Cecilio Granada Andalucia Spain
2 Hospital Carlos Haya Málaga Andalucia Spain
3 Hospital Virgen del Rocio Sevilla Andalucia Spain
4 Hospital Son LLatzer Palma de Mallorca Baleares Spain
5 Hospital Universitario de Canarias La Laguna Canarias Spain
6 Hospital Marques de Valdecilla Santander Cantabria Spain
7 Hospital de Guadalajara Guadalajara Castilla-La Mancha Spain
8 Hospital Vall d'Hebron Barcelona Catalunya Spain 08028
9 Clínic de Barcelona Barcelona Catalunya Spain
10 Hospital de Santa Creu i Sant Pau Barcelona Catalunya Spain
11 Hospital de Bellvitge L'Hospitalet de Llobregat Catalunya Spain
12 Hospital Moises Broggi Sant Joan Despí Catalunya Spain
13 Hospital Clínico San Carlos Madrid Comunidad De Madrid Spain
14 Hospital Infanta Sofía Madrid Comunidad De Madrid Spain
15 Hospital La Paz Madrid Comunidad De Madrid Spain
16 Hospital Puerta de Hierro Madrid Comunidad De Madrid Spain
17 Complexo Hospitalaria A Coruña A Coruña Galicia Spain
18 Hospital de Basurto Bilbao Pais Vasco Spain
19 Hospital Virgen de la Arreixaca Murcia Región De Murcia Spain

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute
  • UCB Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT02804204
Other Study ID Numbers:
  • SMB-CZP- 2014-03
First Posted:
Jun 17, 2016
Last Update Posted:
Feb 7, 2019
Last Verified:
Jun 1, 2016
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Feb 7, 2019