AVIDA The Vidaza® (Azacitidine) Patient Registry

Completed

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT00481273
• Lead Sponsor: Celgene

Brief Summary

This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-31
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-31
• Study First Posted: 2007-06-01
• Primary Completion: 2010-08-31
• Study Completion: 2010-08-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

Inclusion Criteria

• Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment.
• Patient who is able to read and speak English.
• Patient who is willing and able to provide informed consent.
• Patient who agrees to complete patient assessment questionnaires.

Exclusion Criteria

• Patients who are currently being treated with Vidaza®.
• Patients who are concurrently participating in a clinical trial.
• Patients unwilling or unable to complete the baseline and follow-up questionnaires.
• Patients who are deemed inappropriate for treatment with Vidaza®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concomitant care and treatment	Approximately 4 years	Document common concomitant care procedures and treatments used in conjnction wtih Vidaza
Duration and number of cycles	Approximately 4 years	Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome
Vidaza usage	Approximately 4 years	Describe current usage patterns for Vidaza in the community
Publication	Approximately 4 years	Produce publications to support further clinical development and disseminate information on treatment best practices

Trial Locations

Locations (1)

AVIDA Registry Help; 🇺🇸 Kansas City, Missouri, United States