Status:
UNKNOWN
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.
Lead Sponsor:
Osservatorio Epidemiologico GISEA
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 bioma...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01835613
Start Date
January 1 2013
End Date
December 1 2015
Last Update
April 19 2013
Active Locations (1)
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1
Università Cattolica del Sacro Cuore
Roma, Italy