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Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.

NCT01835613 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-04-19

No results posted yet for this study

Summary

The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) \<2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

OTHER

Biomarkers Measures

At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.

Sponsors & Collaborators

  • Osservatorio Epidemiologico GISEA

    lead OTHER

Principal Investigators

  • Gianfranco Ferraccioli, Prof. · Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835613 on ClinicalTrials.gov