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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier:
NCT00481273
First received: May 30, 2007
Last updated: December 31, 2013
Last verified: December 2013
  Purpose
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:

Primary Outcome Measures:
  • Vidaza usage [ Time Frame: Approximately 4 years ] [ Designated as safety issue: No ]
    Describe current usage patterns for Vidaza in the community

  • Concomitant care and treatment [ Time Frame: Approximately 4 years ] [ Designated as safety issue: No ]
    Document common concomitant care procedures and treatments used in conjnction wtih Vidaza

  • Duration and number of cycles [ Time Frame: Approximately 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00481273

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

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00481273     History of Changes
Other Study ID Numbers: AVIDA 
Study First Received: May 30, 2007
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Celgene:
MDS

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

ClinicalTrials.gov processed this record on July 24, 2016