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NCT Number: NCT00267852

Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Iesi, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

as clinical practice

Other

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

Other names: observational study

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.

    Time frame: 12-24 months

Secondary outcomes

  1. -Prevalence of Remission at the second year.

    Time frame: 12-24 months

  2. Disease activity at the 1st and 2nd year

    Time frame: 12-24 months

  3. ACR 20%, 50%, 70% response at the 1st and 2nd year

    Time frame: 12-24 months

  4. QoL in patients with or without remission at the first and second year

    Time frame: 12-24 months

  5. Safety Evaluations

    Time frame: 12-24 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)

Acronym: ARPA

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 21, 2005
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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