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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804204
Recruitment Status : Unknown
Verified June 2016 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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
Rheumatoid Arthritis Drug: Anti-TNF

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Study Type : Observational
Estimated 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 : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Anti-TNF Drug: Anti-TNF



Primary Outcome Measures :
  1. Anti-TNF treatment response based on circulant rheumatoid factor [ Time Frame: 24 weeks ]
  2. Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis according to the ACR criteria
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804204


Contacts
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Contact: Sara Marsal, PhD +34 93 402 90 82

Locations
Show Show 19 study locations
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
UCB Pharma
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02804204    
Other Study ID Numbers: SMB-CZP- 2014-03
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: June 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases