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

NCT00562887 | Terminated Phase 2 DMC

• 2 other identifiers: M10-2222008-004919-36
• Study Type: interventional
• Target: 246
• Locations: 6 countries
• Sites: 60

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

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

  Week 6

Secondary Outcomes (1)

• Patient reported outcomes, clinical response indicators, safety parameters

  Weeks 12 and 24

Study Arms (3)

1

PLACEBO COMPARATOR

Biological: Placebo

400 mg

EXPERIMENTAL

Biological: ABT-874

700mg

EXPERIMENTAL

Biological: ABT-874

Interventions

Placebo BIOLOGICAL

every 4 weeks, IV

1

ABT-874 BIOLOGICAL

400 mg IV every 4 weeks

400 mg

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (61)

Site Ref # / Investigator 6792

Orange, California, 92868, United States

Location

Site Ref # / Investigator 6643

San Diego, California, 92123, United States

Location

Site Ref # / Investigator 6670

Hamden, Connecticut, 06518, United States

Location

Site Ref # / Investigator 6694

Gainesville, Florida, 32610, United States

Location

Site Ref # / Investigator 6794

Jacksonville, Florida, 32256, United States

Location

Site Ref # / Investigator 6687

Winter Park, Florida, 32789, United States

Location

Site Ref # / Investigator 6667

Zephyrhills, Florida, 33542, United States

Location

Site Ref # / Investigator 6691

Atlanta, Georgia, 30308, United States

Location

Site Ref # / Investigator 6642

Atlanta, Georgia, 30342, United States

Location

Site Ref # / Investigator 8797

Macon, Georgia, 31201, United States

Location

Site Ref # / Investigator 6925

Baton Rouge, Louisiana, 70809, United States

Location

Site Ref # / Investigator 6865

Chevy Chase, Maryland, 20815, United States

Location

Site Ref # / Investigator 10202

Towson, Maryland, 21204, United States

Location

Site Ref # / Investigator 6866

Rochester, Minnesota, 55905, United States

Location

Site Ref # / Investigator 6778

Mexico, Missouri, 65265, United States

Location

Site Ref # / Investigator 7048

St Louis, Missouri, 63110, United States

Location

Site Ref # / Investigator 7952

Las Vegas, Nevada, 89128, United States

Location

Site Ref # / Investigator 6647

Cedar Knolls, New Jersey, 07927, United States

Location

Site Ref # / Investigator 6689

Great Neck, New York, 11021, United States

Location

Site Ref # / Investigator 6652

Lake Success, New York, 11042, United States

Location

Site Ref # / Investigator 7047

New York, New York, 10029, United States

Location

Site Ref # / Investigator 6693

Asheville, North Carolina, 28801, United States

Location

Site Ref # / Investigator 6785

Charlotte, North Carolina, 28207, United States

Location

Site Ref # / Investigator 9070

Morgantown, North Carolina, 28655, United States

Location

Site Ref # / Investigator 6651

Raleigh, North Carolina, 27612, United States

Location

Site Ref # / Investigator 6665

Beachwood, Ohio, 44122, United States

Location

Site Ref # / Investigator 6690

Cincinnati, Ohio, 45219, United States

Location

Site Ref # / Investigator 6786

Portland, Oregon, 97220, United States

Location

Site Ref # / Investigator 7004

Germantown, Tennessee, 38138, United States

Location

Site Ref # / Investigator 6648

Nashville, Tennessee, 37203, United States

Location

Site Ref # / Investigator 6793

Nashville, Tennessee, 37205, United States

Location

Site Ref # / Investigator 7054

Nashville, Tennessee, 37212-1610, United States

Location

Site Ref # / Investigator 8357

Round Rock, Texas, 78681, United States

Location

Site Ref # / Investigator 6688

Ogden, Utah, 84405, United States

Location

Site Ref # / Investigator 9115

Chesapeake, Virginia, 23320, United States

Location

Site Ref # / Investigator 6674

Seattle, Washington, 98195, United States

Location

Site Ref # / Investigator 16983

Box Hill, Victoria, 3128, Australia

Location

Site Ref # / Investigator 16225

Vienna, 1090, Austria

Location

Site Ref # / Investigator 16230

Bonheiden, 2820, Belgium

Location

Site Ref # / Investigator 16231

Leuven, 3000, Belgium

Location

Site Ref # / Investigator 9422

Calgary, Alberta, T2N 4Z6, Canada

Location

Site Ref # / Investigator 14042

Edmonton, Alberta, T6G 2X8, Canada

Location

Site Ref # / Investigator 7610

Vancouver, British Columbia, V6Z-2K5, Canada

Location

Site Ref # / Investigator 8206

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Site Ref # / Investigator 7634

St. John's, Newfoundland and Labrador, A1B - 3V6, Canada

Location

Site Ref # / Investigator 7596

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Site Ref # / Investigator 7630

Truro, Nova Scotia, B2N 1L2, Canada

Location

Site Ref # / Investigator 7641

Hamilton, Ontario, L8N 3Z5, Canada

Location

Site Ref # / Investigator 10681

London, Ontario, N6A 5K8, Canada

Location

Site Ref # / Investigator 17901

Toronto, Ontario, M5G 1X5, Canada

Location

Site Ref # / Investigator 7629

Montreal, Quebec, H1T 2M4, Canada

Location

Site Ref # / Investigator 14702

Montreal, Quebec, H3A 1A1, Canada

Location

Site Ref # / Investigator 15061

Montreal, Quebec, H3T 1E2, Canada

Location

Site Ref # / Investigator 17881

Québec, Quebec, G1R 2J6, Canada

Location

Site Ref # / Investigator 7642

Saskatoon, Saskatchewan, S7K 1N4, Canada

Location

Site Ref # / Investigator 14821

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Site Ref # / Investigator 16985

Herlev, DK-2730, Denmark

Location

Site Ref # / Investigator 16235

Hvivdovre, 2650, Denmark

Location

Site Ref # / Investigator 16234

Odense C, 5000, Denmark

Location

Site Ref # / Investigator 10961

Ponce, 00717, Puerto Rico

Location

Site Ref # / Investigator 16801

San Juan, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

briakinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Roberto Carcereri, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

AU (1); BE (2); US (36); CA (16); PR (2); DK (3)