Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis
NCT00267852
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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 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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Descriptive Information | ||||
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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:
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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 | 152 | |||
Original Enrollment | 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
Exclusion Criteria: Exclusion Criteria Based on Clinical Practice of Aggressive RA
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Sex/Gender |
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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 |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2011 |