An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Study Overview
Brief Summary
This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Secondary objective are assessment of:
- Prevalence of Remission at the second year
- Disease activity at the first and second year.
- ACR 20%, 50%, 70% response at the first and second year.
- Quality of Life in patients with or without remission at the first and second year
- Safety Evaluations
Detailed Description
It was expected that approximate 200 patients were enrolled in the study. Have been enrolled 152 patients. A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria Based On Clinical Practice of Aggressive RA
- •Diagnosis of early aggressive RA in accordance with local guideline
- •Disease duration < 2 years and at least six months since onset of symptoms
- •Patients naïve to anti-TNFa drugs and DMARDs, including MTX, or assuming one or more DMARD without complete response
Exclusion Criteria
- •Exclusion Criteria Based on Clinical Practice of Aggressive RA
- •Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.
Outcomes
Primary Outcomes
Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Time Frame: 12-24 months
Secondary Outcomes
- -Prevalence of Remission at the second year.(12-24 months)
- Disease activity at the 1st and 2nd year(12-24 months)
- ACR 20%, 50%, 70% response at the 1st and 2nd year(12-24 months)
- QoL in patients with or without remission at the first and second year(12-24 months)
- Safety Evaluations(12-24 months)