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Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
ABT-874
ABT-874
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Site Ref # / Investigator 6792
  • Site Ref # / Investigator 6643
  • Site Ref # / Investigator 6670
  • Site Ref # / Investigator 6694
  • Site Ref # / Investigator 6794
  • Site Ref # / Investigator 6687
  • Site Ref # / Investigator 6667
  • Site Ref # / Investigator 6691
  • Site Ref # / Investigator 6642
  • Site Ref # / Investigator 8797
  • Site Ref # / Investigator 6925
  • Site Ref # / Investigator 6865
  • Site Ref # / Investigator 10202
  • Site Ref # / Investigator 6866
  • Site Ref # / Investigator 6778
  • Site Ref # / Investigator 7048
  • Site Ref # / Investigator 7952
  • Site Ref # / Investigator 6647
  • Site Ref # / Investigator 6689
  • Site Ref # / Investigator 6652
  • Site Ref # / Investigator 7047
  • Site Ref # / Investigator 6693
  • Site Ref # / Investigator 6785
  • Site Ref # / Investigator 9070
  • Site Ref # / Investigator 6651
  • Site Ref # / Investigator 6665
  • Site Ref # / Investigator 6690
  • Site Ref # / Investigator 6786
  • Site Ref # / Investigator 7004
  • Site Ref # / Investigator 6648
  • Site Ref # / Investigator 6793
  • Site Ref # / Investigator 7054
  • Site Ref # / Investigator 8357
  • Site Ref # / Investigator 6688
  • Site Ref # / Investigator 9115
  • Site Ref # / Investigator 6674
  • Site Ref # / Investigator 16983
  • Site Ref # / Investigator 16225
  • Site Ref # / Investigator 16230
  • Site Ref # / Investigator 16231
  • Site Ref # / Investigator 9422
  • Site Ref # / Investigator 14042
  • Site Ref # / Investigator 7610
  • Site Ref # / Investigator 8206
  • Site Ref # / Investigator 7634
  • Site Ref # / Investigator 7596
  • Site Ref # / Investigator 7630
  • Site Ref # / Investigator 7641
  • Site Ref # / Investigator 10681
  • Site Ref # / Investigator 17901
  • Site Ref # / Investigator 7629
  • Site Ref # / Investigator 14702
  • Site Ref # / Investigator 15061
  • Site Ref # / Investigator 17881
  • Site Ref # / Investigator 7642
  • Site Ref # / Investigator 14821
  • Site Ref # / Investigator 16985
  • Site Ref # / Investigator 16235
  • Site Ref # / Investigator 16234
  • Site Ref # / Investigator 10961
  • Site Ref # / Investigator 16801

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

400 mg

700mg

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points

Secondary Outcome Measures

Patient reported outcomes, clinical response indicators, safety parameters

Full Information

First Posted
November 21, 2007
Last Updated
August 18, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00562887
Brief 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
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
400 mg
Arm Type
Experimental
Arm Title
700mg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
every 4 weeks, IV
Intervention Type
Biological
Intervention Name(s)
ABT-874
Intervention Description
400 mg IV every 4 weeks
Intervention Type
Biological
Intervention Name(s)
ABT-874
Intervention Description
700 mg IV every 4 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Patient reported outcomes, clinical response indicators, safety parameters
Time Frame
Weeks 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Carcereri, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 6792
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site Ref # / Investigator 6643
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Ref # / Investigator 6670
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Site Ref # / Investigator 6694
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Site Ref # / Investigator 6794
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Site Ref # / Investigator 6687
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Site Ref # / Investigator 6667
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Site Ref # / Investigator 6691
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Site Ref # / Investigator 6642
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Site Ref # / Investigator 8797
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Site Ref # / Investigator 6925
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Site Ref # / Investigator 6865
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Site Ref # / Investigator 10202
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Site Ref # / Investigator 6866
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Site Ref # / Investigator 6778
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Site Ref # / Investigator 7048
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Ref # / Investigator 7952
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Site Ref # / Investigator 6647
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
Site Ref # / Investigator 6689
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Site Ref # / Investigator 6652
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site Ref # / Investigator 7047
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Site Ref # / Investigator 6693
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Site Ref # / Investigator 6785
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Site Ref # / Investigator 9070
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Site Ref # / Investigator 6651
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site Ref # / Investigator 6665
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site Ref # / Investigator 6690
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Ref # / Investigator 6786
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Site Ref # / Investigator 7004
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Site Ref # / Investigator 6648
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Site Ref # / Investigator 6793
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Site Ref # / Investigator 7054
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1610
Country
United States
Facility Name
Site Ref # / Investigator 8357
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Site Ref # / Investigator 6688
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Site Ref # / Investigator 9115
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Site Ref # / Investigator 6674
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Site Ref # / Investigator 16983
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Site Ref # / Investigator 16225
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site Ref # / Investigator 16230
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Site Ref # / Investigator 16231
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site Ref # / Investigator 9422
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Site Ref # / Investigator 14042
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Site Ref # / Investigator 7610
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z-2K5
Country
Canada
Facility Name
Site Ref # / Investigator 8206
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Site Ref # / Investigator 7634
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B - 3V6
Country
Canada
Facility Name
Site Ref # / Investigator 7596
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Site Ref # / Investigator 7630
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Site Ref # / Investigator 7641
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Site Ref # / Investigator 10681
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5K8
Country
Canada
Facility Name
Site Ref # / Investigator 17901
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Site Ref # / Investigator 7629
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Site Ref # / Investigator 14702
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Site Ref # / Investigator 15061
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Site Ref # / Investigator 17881
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Site Ref # / Investigator 7642
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N4
Country
Canada
Facility Name
Site Ref # / Investigator 14821
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Site Ref # / Investigator 16985
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Site Ref # / Investigator 16235
City
Hvivdovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Site Ref # / Investigator 16234
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Site Ref # / Investigator 10961
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Site Ref # / Investigator 16801
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

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