Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

NCT00267852

Last updated date
Study Location
Pfizer Investigational Site
Jesi, Ancona, 60035, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis
Official Title An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with early aggressive RA, who are treated in 15 specialized sites
Condition Rheumatoid Arthritis
Intervention Other: as clinical practice
Dosage, form, frequency and duration as per ordinary clinical practice
Other Name: observational study
Study Groups/Cohorts 1.0
As per routinary clinical practice
Intervention: Other: as clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 6, 2008)
152
Original Enrollment
 (submitted: December 19, 2005)
200
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00267852
Other Study ID Numbers 0881A-101749
B1801108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2011