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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.

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ClinicalTrials.gov Identifier: NCT01835613
Recruitment Status : Unknown
Verified April 2013 by Osservatorio Epidemiologico GISEA.
Recruitment status was:  Recruiting
First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Osservatorio Epidemiologico GISEA

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Other: Biomarkers Measures Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Tocilizumab

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.

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.




Primary Outcome Measures :
  1. Disease Activity Score (DAS-44) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Simplified Disease Activity Index (SDAI);Biomarkers Measures [ Time Frame: SDAI at 3-6-12-18 months ]
  2. Biomarkers Measures [ Time Frame: Biomarkers Measures at 3-6-12-18 months ]

    Evaluation by ELISA of the levels of the following biomarkers:

    IL-8, MCP-1, Chemerin, IL-1α, IL-1β, IL-17, IL-23, TGFβ1, IL-10, BAFF.in the plasma:




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Signed informed consent form;
  • Patients aged 18 - 75 years;
  • RA classified in compliance with the 2010 ACR/EULAR criteria;
  • Patients that have to suspend a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and/or patients that have not responded adequately to first-line combination DMARDs / biological treatment;
  • Patients for which is indicated to start a treatment with an inhibitor of IL-6R for high values indicative of systemic inflammation (ESR>=28 mm/hour, PCR>5 mg/l , Fibrinogen >400 mg/dl and or Albumin <3.5 g/dl) and high disease activity (DAS>2.4), or contraindications to DMARDs use which make it necessary to take biological drug in monotherapy.
  • Corticosteroids therapy stable (< = 7.5 mg)for at least four weeks;
  • Joint symptoms for at least three but no more than 24 months from the screening visit;
  • DAS44 >2.4 and/or SDAI >11
  • Willing and able to comply with study procedures and timing.

Exclusion criteria:

  • On going pregnancy or lactation;
  • Severe active infections;
  • Patients with other clinically significant concomitant diseases whose treatment or outcome could interfere with the expected evaluations of the study protocol.
  • Blood AST or ALT levels >5 times the upper normal limit;
  • ANC count <0.5 x 109/L
  • Platelet count <50 x103 /μL
  • Patients with other autoimmune rheumatic diseases, in addition to AR (for example systemic lupus erythematosus [SLE], scleroderma, polymyositis, ecc…)
  • Medical history or concomitant joint diseases in additions to AR (for example tophaceous gout, reactive arthritis, psoriatic arthritis).

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): NCT01835613


Contacts
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Contact: Giovanni Lapadula, Prof. +39 080 5478866 info@oegisea.it

Locations
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Italy
Università Cattolica del Sacro Cuore Recruiting
Roma, Italy
Sponsors and Collaborators
Osservatorio Epidemiologico GISEA
Investigators
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Principal Investigator: Gianfranco Ferraccioli, Prof. Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma

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Responsible Party: Osservatorio Epidemiologico GISEA
ClinicalTrials.gov Identifier: NCT01835613     History of Changes
Other Study ID Numbers: AR/BIOM
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

Keywords provided by Osservatorio Epidemiologico GISEA:
Rheumatoid Arthritis
Early RA
RA
IL-6
IL-6R
Inhibitor
Inhibition
Tocilizumab
Biomarkers
DMARDs
Biological
DAS
SDAI
AR/BIOM
OEG

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