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AVIDA The Vidaza® (Azacitidine) Patient Registry

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

May 30, 2007
December 31, 2013
October 2006
August 2010   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00481273 on ClinicalTrials.gov 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.

Not Provided
Observational
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)
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
479
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®.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
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NCT00481273
AVIDA
No
Celgene Corporation
Celgene Corporation
Not Provided
Principal Investigator: David L. Grinblatt, MD NorthShore University HealthSystem Research Institute
Celgene Corporation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP