study details
start date: November 2004
estimated completion: November 2008
last updated: March 9, 2010
size / enrollment: 68
study design:
Observational Model: Cohort
study description:
The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
primary outcomes:
- Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA [ Time Frame: Up to 8 years prior to baseline ] [ Designated as safety issue: No ]
Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
- Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.
- Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1]
divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
- Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.
secondary outcomes:
- Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps) [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.
- Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.
- Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
- Time From Start of Study Follow-up to Time of First FAP-related Adverse Event [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
- Time From Post IRA to Time of Conversion From IRA to IPAA [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.
- Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.
- Duodenal Adenoma Burden as Measured by Spigelman Stage [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ] [ Designated as safety issue: No ]
Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.
- Rectal or Pouch Adenoma Burden Based on Polyp Counts [ Time Frame: Baseline, 6 to 14 months post-baseline, EOS ] [ Designated as safety issue: No ]
Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: 1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).
inclusion criteria:
• Eligible Sexes:
Celecoxib Treated Patients:
- Diagnosis of FAP based on the expression of the FAP phenotype.
- Celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months.
Historical/Concurrent Control Patients:
- Diagnosis of FAP based on the expression of the FAP phenotype.
- Be greater than or equal to 12 years old at the time of study enrollment.
- Have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment.
- For the group of post-surgical patients, IRA or IPAA performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). Patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls.
exclusion criteria:
Celecoxib Treated Patients:
- Have received a pharmacological treatment (other than celecoxib) within the last 3 months for their FAP disease including treatment of any extracolonic manifestation of FAP.
- Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months, other than celecoxib, for any reason.
Historical/Concurrent Control Patients:
- Have pharmacological treatment recorded for their FAP disease at the defined index date.
- Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months for any reason.
