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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.
ClinicalTrials.gov Identifier: NCT00481273
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

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.

Condition or disease Intervention/treatment
Myelodysplastic Syndromes Drug: Azacitidine

Study Type : Observational
Actual Enrollment : 479 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AVIDA The Vidaza® (Azacitidine) Patient Registry
Study Start Date : October 2006
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine
U.S. FDA Resources

Intervention Details:
    Drug: Azacitidine
    Physician's discretion
    Other Name: Vidaza(R)

Primary Outcome Measures :
  1. Vidaza usage [ Time Frame: Approximately 4 years ]
    Describe current usage patterns for Vidaza in the community

  2. Concomitant care and treatment [ Time Frame: Approximately 4 years ]
    Document common concomitant care procedures and treatments used in conjnction wtih Vidaza

  3. 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

  4. Publication [ Time Frame: Approximately 4 years ]
    Produce publications to support further clinical development and disseminate information on treatment best practices

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community-based hematology/oncology centers

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®.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481273

Sponsors and Collaborators
Celgene Corporation
Principal Investigator: David L. Grinblatt, MD NorthShore University HealthSystem Research Institute

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00481273     History of Changes
Other Study ID Numbers: AVIDA
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: December 2013

Keywords provided by Celgene ( Celgene Corporation ):

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors