Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
OSSERVATORIO EPIDEMIOLOGICO GISEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written Informed Consent; 2) Patients aged 18-75 years; 3) RA classified using the 2010 ACR/EULAR criteria; 4) Patients who have had to interrupt a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and / or patients who have not responded adequately to a combination of a first-line combination of DMARD / biological treatment; 5) Patients in whom it is indicated starting a treatment with an inhibitor of IL-6R, for values ??indicative of high systemic inflammation (ESR = 28 mm/h, PCR> 5 mg/l, Fibrinogen> 400 mg/dl and / or albumin 2.4), or contraindications to the use of DMARDs that should take a biologic drug monotherapy;6) Treatment with corticosteroids at a stable dose (=7.5 mg) for at least 4 weeks; 7) Joint symptoms for at least three but no more than 24 months from the screening visit (early RA); 8) DAS44 >2.4 and/or SDAI >11 (moderate or high activity); 9) Patients able to comply with the procedures and timing of the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1) Ongoing pregnancy or lactation; 2) Severe active infections; 3) Patients with other clinically significant concomitant diseases, whose treatment and outcome are able to interfere with the evaluation required by the study protocol; 4) Blood AST or ALT > 1.5 times the upper normal limit; 5) ANC count < 2 x 103/µl; 6) Platelet count < 100 x 103/µl; 7) Patients with other autoimmune rheumatic diseases in addition to the RA (eg,systemic lupus erythematosus [SLE], scleroderma, polymyositis, etc ...); 8) Clinical history or presence of other concomitant inflammatory diseases in addition to RA ( tophaceous gout, reactive arthritis, psoriatic arthritis, etc. ...).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the clinical response to the inhibition of the IL-6R,defined as an achievement of a low disease activity(value of the Disease Activity Score (DAS 44)<2.4) at follow-up visit at 12 months and to correlate it to the biomarkers.;Secondary Objective: The secondary objective of the study is to evaluate the correlation between changes from baseline in the biomarkers and in the treatment response, defined as Remission - DAS-44 <1.6 or Simplified Disease Activity Index (ICSD) <3.3, in addition to the DAS of at least 1.2, at all follow-up visits.;Primary end point(s): The primary efficacy variables for the study is the Disease Activity Score (DAS-44)at follow-up visit at 12 months.;Timepoint(s) of evaluation of this end point: At follow-up visit at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables for the study are the following: Disease Activity Score (DAS-44)at all other times, Simplified Disease Activity Index (SDAI) and measurement of the biomarkers at all follow-up visits.;Timepoint(s) of evaluation of this end point: Disease Activity Score (DAS-44)at 3,6,18 months from baseline. Simplified Disease Activity Index (SDAI) and measurement of the biomarkers at 3,6,12 and 18 months from baseline. | — |
Countries
Italy
Contacts
Public ContactB.U. CRO
CD Pharma Group S.r.l.
Outcome results
None listed