AVIDA The Vidaza® (Azacitidine) Patient Registry

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00481273
• Collaborator: (none)
• Enrollment: 479
• Location: 1
• Actual Duration (Months): 46
• Patients Per Site Per Month: 10.4

Study Details

Study Description

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	Phase
Myelodysplastic Syndromes	Drug: Azacitidine

Study Design

• Study Type: Observational
• Actual Enrollment: 479 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: AVIDA The Vidaza® (Azacitidine) Patient Registry
• Actual Study Start Date: Oct 31, 2006
• Actual Primary Completion Date: Aug 31, 2010
• Actual Study Completion Date: Aug 31, 2010

Outcome Measures

Primary Outcome Measures

1. Vidaza usage [Approximately 4 years]

   Describe current usage patterns for Vidaza in the community

2. Concomitant care and treatment [Approximately 4 years]

   Document common concomitant care procedures and treatments used in conjnction wtih Vidaza

3. Duration and number of cycles [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 [Approximately 4 years]

   Produce publications to support further clinical development and disseminate information on treatment best practices

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	AVIDA Registry Help	Kansas City	Missouri	United States	66210

Sponsors and Collaborators

• Celgene

Investigators

• Principal Investigator: David L. Grinblatt, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

• Grinblatt DL, Sekeres MA, Komrokji RS, Swern AS, Sullivan KA, Narang M. Patients with myelodysplastic syndromes treated with azacitidine in clinical practice: the AVIDA registry. Leuk Lymphoma. 2015 Apr;56(4):887-95. doi: 10.3109/10428194.2014.935366. Epub 2014 Aug 20.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT00481273
• Other Study ID Numbers: AVIDA
• First Posted: Jun 1, 2007
• Last Update Posted: May 3, 2018
• Last Verified: May 1, 2018

• Keywords provided by Celgene: MDS
• Additional relevant MeSH terms: Myelodysplastic Syndromes; Azacitidine

Study Results

No Results Posted as of May 3, 2018