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

Condition
Rheumatoid Arthritis

Further study details as provided by Wyeth:

Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00267852

Trial Manager       clinicaltrialinfo@wyeth.com

Italy
      Torino,  10128,  Italy
      Arenzano,  16011,  Italy
      Pavia,  27100,  Italy
      Ferrara,  44100,  Italy
      Palermo,  90127,  Italy
      Padova,  35128,  Italy
      Bari,  70124,  Italy
      Roma,  00161,  Italy
      Pisa,  56126,  Italy
      Napoli,  Italy
      Siena,  53100,  Italy
      Jesi,  60035,  Italy
      Messina,  98122,  Italy
      Genova,  Italy
      Brescia,  Italy

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   
Trial Manager,  Principal Investigator,  For Italy, decresg@wyeth.com   

Study ID Numbers:  0881A-101749
Last Updated:  December 20, 2005
Record first received:  December 19, 2005
ClinicalTrials.gov Identifier:  NCT00267852
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2006-01-10