Text Size

AVIDA The Vidaza® (Azacitidine) Patient Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Celgene Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00481273
First received: May 30, 2007
Last updated: February 22, 2010
Last verified: February 2010
History of Changes
  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:

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

Further study details as provided by Celgene Corporation:

Estimated Enrollment: 500
Study Start Date: October 2006
Estimated Study Completion Date: June 2010
Intervention Details:
    Drug: Azacitidine
    Physician's discretion
    Other Name: Vidaza(R)
  Eligibility

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481273

Locations
United States, Missouri
AVIDA Registry Help
Kansas City, Missouri, United States, 66210
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: David L. Grinblatt, MD NorthShore University HealthSystem Research Institute
  More Information

Additional Information:
Click here for more information about the registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kristen Sullivan, Specialist, Disease Registry Projects, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00481273     History of Changes
Other Study ID Numbers: AVIDA
Study First Received: May 30, 2007
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Celgene Corporation:
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013