Cost-effectiveness of TPMT Pharmacogenetics

NACompletedINTERVENTIONAL
Enrollment

853

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Inflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis
Interventions
GENETIC

TPMT genotyping; Drug: azathioprine or 6-mercaptopurine

"Assessment of the polymorphisms G238C, G460A, and A719G in a venous blood sample to identify functional genetic variants (TPMT\*2, \*3A, \*3C) of the TPMT gene (chromosome 6) associated with reduced or negligible TPMT enzyme activity.~Patients are advised an initial treatment dose based on the enzyme activity:~* Normal: AZA 2-2.5 mg/kg/day or 6-MP 1-1.5 mg/kg/day (standard care);~* Reduced: AZA 1-1.25 mg/kg/day or 6-MP 0.5-0.75 mg/kg/day;~* Negligible: AZA 0-0.2 mg/kg/day or 6-MP 0-0.1 mg/kg/day;"

DRUG

azathioprine (AZA) or 6-mercaptopurine (6-MP)

"Patients will be advised a standard initial treatment dose:~* AZA 2-2.5 mg/kg/day or 6-MP 1-1.5 mg/kg/day (standard care);"

Trial Locations (3)

6500 HB

Radboud University Medical Center, Nijmegen

5342 BT

Bernhoven Hospital, Oss

5461 AA

Bernhoven Hospital, Veghel

All Listed Sponsors
collaborator

Radboud University Medical Center

OTHER

lead

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

NCT00521950 - Cost-effectiveness of TPMT Pharmacogenetics | Biotech Hunter | Biotech Hunter