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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00562887




Registration number
NCT00562887
Ethics application status
Date submitted
21/11/2007
Date registered
26/11/2007
Date last updated
23/08/2011

Titles & IDs
Public title
Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
Scientific title
A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.
Secondary ID [1] 0 0
2008-004919-36
Secondary ID [2] 0 0
M10-222
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - ABT-874
Other interventions - ABT-874

Placebo Comparator: 1 -

Experimental: 400 mg -

Experimental: 700mg -


Other interventions: Placebo
every 4 weeks, IV

Other interventions: ABT-874
400 mg IV every 4 weeks

Other interventions: ABT-874
700 mg IV every 4 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Patient reported outcomes, clinical response indicators, safety parameters
Timepoint [1] 0 0
Weeks 12 and 24

Eligibility
Key inclusion criteria
- Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or
radiologic evaluation.

- CDAI score of >= 220 and <= 450 at Week 0.

- Males and females >= 18 years and < 75 years of age at the Screening visit.

- Judged to be in generally good health as determined by the Investigator.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current diagnosis of the colitis other than Crohn's disease.

- Symptomatic known strictures.

- Surgical bowel resections within the past 6 months or is planning any resection at any
time point while enrolled in the study.

- Ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not
excluded).

- Short bowel syndrome as determined by the investigator.

- Infection or risk factors for severe infections.

- Females who are pregnant or considering becoming pregnant during the study, or
breast-feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Site Ref # / Investigator 16983 - Box Hill
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Belgium
State/province [21] 0 0
Bonheiden
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Newfoundland and Labrador
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Saskatchewan
Country [31] 0 0
Denmark
State/province [31] 0 0
Herlev
Country [32] 0 0
Denmark
State/province [32] 0 0
Hvivdovre
Country [33] 0 0
Denmark
State/province [33] 0 0
Odense C
Country [34] 0 0
Puerto Rico
State/province [34] 0 0
Ponce
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who
have moderately to severely active Crohn's Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00562887
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roberto Carcereri, MD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00562887