Back to resultsEvaluation 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.
Primary Purpose
Rheumatoid Arthritis (RA)
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Biomarkers Measures
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Rheumatoid Arthritis, Early RA, RA, IL-6, IL-6R, Inhibitor, Inhibition, Tocilizumab, Biomarkers, DMARDs, Biological, DAS, SDAI, AR/BIOM, OEG
Eligibility 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).
Sites / Locations
- Università Cattolica del Sacro CuoreRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tocilizumab
Arm Description
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.
Outcomes
Primary Outcome Measures
Disease Activity Score (DAS-44)
Secondary Outcome Measures
Simplified Disease Activity Index (SDAI);Biomarkers Measures
Biomarkers Measures
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:
Full Information
NCT ID
NCT01835613
First Posted
April 1, 2013
Last Updated
April 18, 2013
Sponsor
Osservatorio Epidemiologico GISEA
1. Study Identification
Unique Protocol Identification Number
NCT01835613
Brief 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.
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osservatorio Epidemiologico GISEA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Rheumatoid Arthritis, Early RA, RA, IL-6, IL-6R, Inhibitor, Inhibition, Tocilizumab, Biomarkers, DMARDs, Biological, DAS, SDAI, AR/BIOM, OEG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biomarkers Measures
Intervention Description
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 Measure Information:
Title
Disease Activity Score (DAS-44)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Simplified Disease Activity Index (SDAI);Biomarkers Measures
Time Frame
SDAI at 3-6-12-18 months
Title
Biomarkers Measures
Description
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:
Time Frame
Biomarkers Measures at 3-6-12-18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Lapadula, Prof.
Phone
+39 080 5478866
Email
info@oegisea.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianfranco Ferraccioli, Prof.
Organizational Affiliation
Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università Cattolica del Sacro Cuore
City
Roma
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
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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