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.
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis
Early RA
RA
IL-6
IL-6R
Inhibitor
Inhibition
Tocilizumab
Biomarkers
DMARDs
Biological
DAS
SDAI
AR/BIOM
OEG
Lead sponsor: Osservatorio Epidemiologico GISEA
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Disease Activity Score (DAS-44)
timeFrame: 12 months
Secondary outcomes:
measure: Simplified Disease Activity Index (SDAI);Biomarkers Measures
timeFrame: SDAI at 3-6-12-18 months
measure: Biomarkers Measures
timeFrame: Biomarkers Measures at 3-6-12-18 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
Study officials:
affiliation: Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma
name: Gianfranco Ferraccioli, Prof.
role: PRINCIPAL_INVESTIGATOR
References: