Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis (ARPA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00267852
First received: December 19, 2005
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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

Condition Intervention Phase
Rheumatoid Arthritis
Other: as clinical practice
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • -Prevalence of Remission at the second year. [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
  • Disease activity at the 1st and 2nd year [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
  • ACR 20%, 50%, 70% response at the 1st and 2nd year [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
  • QoL in patients with or without remission at the first and second year [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
  • Safety Evaluations [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: April 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1.0
As per routinary clinical practice
Other: as clinical practice
Dosage, form, frequency and duration as per ordinary clinical practice
Other Name: observational study

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267852

Locations
Italy
Pfizer Investigational Site
Jesi, Ancona, Italy, 60035
Pfizer Investigational Site
Napoli, Campania, Italy, 80131
Pfizer Investigational Site
Ferrara, Ferrara (FE), Italy, 44100
Pfizer Investigational Site
Arenzano, GE, Italy, 16011
Pfizer Investigational Site
Roma, Lazio, Italy, 00161
Pfizer Investigational Site
Bari, Puglia, Italy, 70124
Pfizer Investigational Site
Messina, Sicily, Italy, 98127
Pfizer Investigational Site
Pisa, Toscana, Italy, 56126
Pfizer Investigational Site
Brescia, Italy, 25125
Pfizer Investigational Site
Genova, Italy
Pfizer Investigational Site
Messina, Italy, 98122
Pfizer Investigational Site
Padova, Italy, 35128
Pfizer Investigational Site
Palermo, Italy, 90100
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Torino, Italy, 10128
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00267852     History of Changes
Other Study ID Numbers: 0881A-101749, B1801108
Study First Received: December 19, 2005
Last Updated: September 14, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014