Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

NCT00267852 | Completed DMC

• 2 other identifiers: 0881A-101749B1801108
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 16

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

Conditions

Rheumatoid Arthritis

Keywords

Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  12-24 months

Secondary Outcomes (5)

• -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

Study Arms (1)

1.0

As per routinary clinical practice

Other: as clinical practice

Interventions

as clinical practice OTHER

Dosage, form, frequency and duration as per ordinary clinical practice

Also known as: observational study

1.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early aggressive RA, who are treated in 15 specialized sites

You may qualify if:

• 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

You may not qualify if:

• Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (16)

Pfizer Investigational Site

Iesi, Ancona, 60035, Italy

Location

Pfizer Investigational Site

Bari, Apulia, 70124, Italy

Location

Pfizer Investigational Site

Napoli, Campania, 80131, Italy

Location

Pfizer Investigational Site

Ferrara, Ferrara (FE), 44100, Italy

Location

Pfizer Investigational Site

Arenzano, GE, 16011, Italy

Location

Pfizer Investigational Site

Rome, Lazio, 00161, Italy

Location

Pfizer Investigational Site

Messina, Messina, 98122, Italy

Location

Pfizer Investigational Site

Padua, Padova, 35128, Italy

Location

Pfizer Investigational Site

Palermo, Palermo, 90100, Italy

Location

Pfizer Investigational Site

Messina, Sicily, 98127, Italy

Location

Pfizer Investigational Site

Siena, Siena, 53100, Italy

Location

Pfizer Investigational Site

Pisa, Tuscany, 56126, Italy

Location

Pfizer Investigational Site

Brescia, 25125, Italy

Location

Pfizer Investigational Site

Genova, Italy

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

Pfizer Investigational Site

Torino, 10128, Italy

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Practice Guidelines as Topic; Observation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Methods; Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 21, 2005
• Study Start: April 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

IT (16)