- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835613
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.
April 18, 2013 updated by: Osservatorio Epidemiologico GISEA
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Giovanni Lapadula, Prof.
- Phone Number: +39 080 5478866
- Email: info@oegisea.it
Study Locations
-
-
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Roma, Italy
- Recruiting
- Università Cattolica del Sacro Cuore
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease Activity Score (DAS-44)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Simplified Disease Activity Index (SDAI);Biomarkers Measures
Time Frame: SDAI at 3-6-12-18 months
|
SDAI at 3-6-12-18 months
|
|
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: |
Biomarkers Measures at 3-6-12-18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gianfranco Ferraccioli, Prof., Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
April 1, 2013
First Submitted That Met QC Criteria
April 18, 2013
First Posted (Estimate)
April 19, 2013
Study Record Updates
Last Update Posted (Estimate)
April 19, 2013
Last Update Submitted That Met QC Criteria
April 18, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR/BIOM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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