This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Celgene ( Celgene Corporation ) Identifier:
First received: May 30, 2007
Last updated: December 31, 2013
Last verified: December 2013
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 Intervention
Myelodysplastic Syndromes Drug: Azacitidine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AVIDA The Vidaza® (Azacitidine) Patient Registry

Resource links provided by NLM:

Further study details as provided by Celgene ( Celgene Corporation ):

Primary Outcome Measures:
  • 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

Enrollment: 479
Study Start Date: October 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Azacitidine
    Physician's discretion
    Other Name: Vidaza(R)

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®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00481273

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

Responsible Party: Celgene Corporation Identifier: NCT00481273     History of Changes
Other Study ID Numbers: AVIDA
Study First Received: May 30, 2007
Last Updated: December 31, 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 processed this record on August 18, 2017