AVIDA The Vidaza® (Azacitidine) Patient Registry (AVIDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481273
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

May 30, 2007
June 1, 2007
January 3, 2014
October 2006
August 2010   (Final data collection date for primary outcome measure)
  • Vidaza usage [ Time Frame: Approximately 4 years ]
    Describe current usage patterns for Vidaza in the community
  • Concomitant care and treatment [ Time Frame: Approximately 4 years ]
    Document common concomitant care procedures and treatments used in conjnction wtih Vidaza
  • Duration and number of cycles [ Time Frame: Approximately 4 years ]
    Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome
  • Publication [ Time Frame: Approximately 4 years ]
    Produce publications to support further clinical development and disseminate information on treatment best practices
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Complete list of historical versions of study NCT00481273 on Archive Site
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AVIDA The Vidaza® (Azacitidine) Patient Registry
AVIDA The Vidaza® (Azacitidine) Patient Registry
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Community-based hematology/oncology centers
Myelodysplastic Syndromes
Drug: Azacitidine
Physician's discretion
Other Name: Vidaza(R)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (Final data collection date for primary outcome measure)

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®.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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United States
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Celgene ( Celgene Corporation )
Celgene Corporation
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Principal Investigator: David L. Grinblatt, MD NorthShore University HealthSystem Research Institute
December 2013