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

August 18, 2011 updated by: Abbott

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.

To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 1
Biological: Placebo
every 4 weeks, IV
Experimental: 400 mg
Biological: ABT-874
400 mg IV every 4 weeks
Biological: ABT-874
700 mg IV every 4 weeks
Experimental: 700mg
Biological: ABT-874
400 mg IV every 4 weeks
Biological: ABT-874
700 mg IV every 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patient reported outcomes, clinical response indicators, safety parameters
Time Frame: Weeks 12 and 24
Weeks 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Roberto Carcereri, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M10-222
  • 2008-004919-36 (Registry Identifier: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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