Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy

Conditions: Rheumatoid Arthritis
MedDRA version: 14.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-003016-23-IT

Lead Sponsor: GUNA SPA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Rheumatoid Arthritis, duration of the disease <3 years, activity of disease on 28 articulation DAS28<3.2, patients who have reached the remission disease or low residual disease after treatment with DMARDs (MTX, CyA, Leflunamide), patients who are able to understand study procedure and to fill in a questionnaire and to give the Informed Consensus.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

age <18 years, duration of the disease >3 years, patients with disease that could damage the treatment with Biologic drugs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Estimating that the proportion of patients who maintain the remission after the therapy of active branch is greater than or equal respect of patients in control branch.;Secondary Objective: Estimating for how long the patients with Reumatoid Arthritis using IL-4, IL-10, anti IL-1 4CH can keep the low activity disease after DMARDs or Biologics versus the DMARDs treatment.;Primary end point(s): Estimating for how long the treatment with low dose of IL-4, IL-10 antiIL-1 can maintain the remission obtained after Biologics drugs anti-TNF or DMARDS therapy.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Estimating the share of patients who use Biologic therapy in two different branches therapy. Estimating the use of Methotrexate, Steroids and FANS into two branches. Estimating the efficacy of therapy with low dose IL-4, IL-10 and Anti-IL-1 on maintenance the remission of disease after Biologic therapy. Monitoring and estimating the severity, the duration and the correlation with research product of Adverse Events during the therapy.;Timepoint(s) of evaluation of this end point: 12 months