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

Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDY

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003016-23-IT
Enrollment
Unknown
Registered
2012-03-07
Start date
2011-05-11
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: Guna-Anti Interleukin 1 Product Code: NA Pharmaceutical Form: Oral drops INN or Proposed INN: NA CAS Number: NA Current Sponsor code: 36172 Other descriptive name: Guna-Antiinterleukin 1

Sponsors

GUNA SPA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Rheumatoid Arthritis, duration of the disease =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: age 3 years, patients with disease that could damage the treatment with Biologic drugs.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactSegreteria ANTIAGE

ANTIAGE onlus

albertomigliore@terra.es06.33585802

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026