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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

Sponsor
Abbott (Industry)
Overall Status
Terminated
CT.gov ID
NCT00562887
Collaborator
(none)
246
Enrollment
61
Locations
3
Arms
4
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Placebo
  • Biological: ABT-874
  • Biological: ABT-874
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Biological: Placebo
every 4 weeks, IV
Experimental: 400 mg

Biological: ABT-874
400 mg IV every 4 weeks
Experimental: 700mg

Biological: ABT-874
700 mg IV every 4 weeks

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points [Week 6]

Secondary Outcome Measures

  1. Patient reported outcomes, clinical response indicators, safety parameters [Weeks 12 and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site Ref # / Investigator 6792 Orange California United States 92868
2 Site Ref # / Investigator 6643 San Diego California United States 92123
3 Site Ref # / Investigator 6670 Hamden Connecticut United States 06518
4 Site Ref # / Investigator 6694 Gainesville Florida United States 32610
5 Site Ref # / Investigator 6794 Jacksonville Florida United States 32256
6 Site Ref # / Investigator 6687 Winter Park Florida United States 32789
7 Site Ref # / Investigator 6667 Zephyrhills Florida United States 33542
8 Site Ref # / Investigator 6691 Atlanta Georgia United States 30308
9 Site Ref # / Investigator 6642 Atlanta Georgia United States 30342
10 Site Ref # / Investigator 8797 Macon Georgia United States 31201
11 Site Ref # / Investigator 6925 Baton Rouge Louisiana United States 70809
12 Site Ref # / Investigator 6865 Chevy Chase Maryland United States 20815
13 Site Ref # / Investigator 10202 Towson Maryland United States 21204
14 Site Ref # / Investigator 6866 Rochester Minnesota United States 55905
15 Site Ref # / Investigator 6778 Mexico Missouri United States 65265
16 Site Ref # / Investigator 7048 St. Louis Missouri United States 63110
17 Site Ref # / Investigator 7952 Las Vegas Nevada United States 89128
18 Site Ref # / Investigator 6647 Cedar Knolls New Jersey United States 07927
19 Site Ref # / Investigator 6689 Great Neck New York United States 11021
20 Site Ref # / Investigator 6652 Lake Success New York United States 11042
21 Site Ref # / Investigator 7047 New York New York United States 10029
22 Site Ref # / Investigator 6693 Asheville North Carolina United States 28801
23 Site Ref # / Investigator 6785 Charlotte North Carolina United States 28207
24 Site Ref # / Investigator 9070 Morgantown North Carolina United States 28655
25 Site Ref # / Investigator 6651 Raleigh North Carolina United States 27612
26 Site Ref # / Investigator 6665 Beachwood Ohio United States 44122
27 Site Ref # / Investigator 6690 Cincinnati Ohio United States 45219
28 Site Ref # / Investigator 6786 Portland Oregon United States 97220
29 Site Ref # / Investigator 7004 Germantown Tennessee United States 38138
30 Site Ref # / Investigator 6648 Nashville Tennessee United States 37203
31 Site Ref # / Investigator 6793 Nashville Tennessee United States 37205
32 Site Ref # / Investigator 7054 Nashville Tennessee United States 37212-1610
33 Site Ref # / Investigator 8357 Round Rock Texas United States 78681
34 Site Ref # / Investigator 6688 Ogden Utah United States 84405
35 Site Ref # / Investigator 9115 Chesapeake Virginia United States 23320
36 Site Ref # / Investigator 6674 Seattle Washington United States 98195
37 Site Ref # / Investigator 16983 Box Hill Victoria Australia 3128
38 Site Ref # / Investigator 16225 Vienna Austria 1090
39 Site Ref # / Investigator 16230 Bonheiden Belgium 2820
40 Site Ref # / Investigator 16231 Leuven Belgium 3000
41 Site Ref # / Investigator 9422 Calgary Alberta Canada T2N 4Z6
42 Site Ref # / Investigator 14042 Edmonton Alberta Canada T6G 2X8
43 Site Ref # / Investigator 7610 Vancouver British Columbia Canada V6Z-2K5
44 Site Ref # / Investigator 8206 Winnipeg Manitoba Canada R3A 1R9
45 Site Ref # / Investigator 7634 St. John's Newfoundland and Labrador Canada A1B - 3V6
46 Site Ref # / Investigator 7596 Halifax Nova Scotia Canada B3H 2Y9
47 Site Ref # / Investigator 7630 Truro Nova Scotia Canada B2N 1L2
48 Site Ref # / Investigator 7641 Hamilton Ontario Canada L8N 3Z5
49 Site Ref # / Investigator 10681 London Ontario Canada N6A 5K8
50 Site Ref # / Investigator 17901 Toronto Ontario Canada M5G 1X5
51 Site Ref # / Investigator 7629 Montreal Quebec Canada H1T 2M4
52 Site Ref # / Investigator 14702 Montreal Quebec Canada H3A 1A1
53 Site Ref # / Investigator 15061 Montreal Quebec Canada H3T 1E2
54 Site Ref # / Investigator 17881 Quebec City Quebec Canada G1R 2J6
55 Site Ref # / Investigator 7642 Saskatoon Saskatchewan Canada S7K 1N4
56 Site Ref # / Investigator 14821 Saskatoon Saskatchewan Canada S7N 0W8
57 Site Ref # / Investigator 16985 Herlev Denmark DK-2730
58 Site Ref # / Investigator 16235 Hvivdovre Denmark 2650
59 Site Ref # / Investigator 16234 Odense C Denmark 5000
60 Site Ref # / Investigator 10961 Ponce Puerto Rico 00717
61 Site Ref # / Investigator 16801 San Juan Puerto Rico 00935

Sponsors and Collaborators

  • Abbott

Investigators

  • Study Director: Roberto Carcereri, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT00562887
Other Study ID Numbers:
  • M10-222
  • 2008-004919-36
First Posted:
Nov 26, 2007
Last Update Posted:
Aug 23, 2011
Last Verified:
Aug 1, 2011
Keywords provided by Abbott
Crohn's Disease
Additional relevant MeSH terms:
Crohn Disease
Antibodies, Monoclonal

Study Results

No Results Posted as of Aug 23, 2011