Clinical trial NCT00308438: Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
Official title: An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn Disease
Crohn's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-03-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Detailed description: The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.

Eligibility criteria: Inclusion Criteria:

* Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
* Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

  * CDAI score greater than 220
  * Stool samples not required
  * C-reactive protein levels are not an exclusion criterion

Exclusion Criteria:

* Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

  * Participation in a clinical study of an experimental drug or device within 30 days before signing consent.

Primary outcomes:
measure: The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.
timeFrame: 12 weeks after start of study
Secondary outcomes:
measure: The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved.
timeFrame: 12 weeks after study start
measure: The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study
timeFrame: 12 weeks after study start
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Washington
country: United States
facility: Rx Trials
state: District of Columbia
city: Boca Raton
country: United States
facility: Clinical Trials Management of Boca Raton
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: North Miami Beach
country: United States
facility: Venture Research
state: Florida
city: Atlanta
country: United States
facility: Pinnacle Trials
state: Georgia
city: Atlanta
country: United States
facility: Saint Joseph's Health System
state: Georgia
city: Chicago
country: United States
facility: Northwestern University School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Asher Kornbluth, MD, PC
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Houston
country: United States
facility: Atilla Ertan
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Madison
country: United States
facility: Dean Foundation Research Center
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences
state: Nova Scotia
city: Toronto
country: Canada
facility: Life Screening Centres
state: Ontario
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.