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

A Phase 2 study testing ABT-874 in people with Crohn's Disease, run by Abbott at 61 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Crohn's Disease
What is being tested?: ABT-874
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 246 participants
Where: 61 sitesin 7 countries
Study dates: Nov 2007to Apr 2010
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

61 sites in 7 countries.

Country

City, postcode or hospital

61 sites in 7 countries

United States36 sites

Site Ref # / Investigator 6693
Asheville, North Carolina, 28801
Site Ref # / Investigator 6691
Atlanta, Georgia, 30308
Site Ref # / Investigator 6642
Atlanta, Georgia, 30342
Site Ref # / Investigator 6925
Baton Rouge, Louisiana, 70809
Site Ref # / Investigator 6665
Beachwood, Ohio, 44122
Site Ref # / Investigator 6647
Cedar Knolls, New Jersey, 07927
Site Ref # / Investigator 6785
Charlotte, North Carolina, 28207
Site Ref # / Investigator 9115
Chesapeake, Virginia, 23320
Site Ref # / Investigator 6865
Chevy Chase, Maryland, 20815
Site Ref # / Investigator 6690
Cincinnati, Ohio, 45219
Site Ref # / Investigator 6694
Gainesville, Florida, 32610
Site Ref # / Investigator 7004
Germantown, Tennessee, 38138
Site Ref # / Investigator 6689
Great Neck, New York, 11021
Site Ref # / Investigator 6670
Hamden, Connecticut, 06518
Site Ref # / Investigator 6794
Jacksonville, Florida, 32256
Site Ref # / Investigator 6652
Lake Success, New York, 11042
Site Ref # / Investigator 7952
Las Vegas, Nevada, 89128
Site Ref # / Investigator 8797
Macon, Georgia, 31201
Site Ref # / Investigator 6778
Mexico, Missouri, 65265
Site Ref # / Investigator 9070
Morgantown, North Carolina, 28655
Site Ref # / Investigator 6648
Nashville, Tennessee, 37203
Site Ref # / Investigator 6793
Nashville, Tennessee, 37205
Site Ref # / Investigator 7054
Nashville, Tennessee, 37212-1610
Site Ref # / Investigator 7047
New York, New York, 10029
Site Ref # / Investigator 6688
Ogden, Utah, 84405
Site Ref # / Investigator 6792
Orange, California, 92868
Site Ref # / Investigator 6786
Portland, Oregon, 97220
Site Ref # / Investigator 6651
Raleigh, North Carolina, 27612
Site Ref # / Investigator 6866
Rochester, Minnesota, 55905
Site Ref # / Investigator 8357
Round Rock, Texas, 78681
Site Ref # / Investigator 6643
San Diego, California, 92123
Site Ref # / Investigator 6674
Seattle, Washington, 98195
Site Ref # / Investigator 7048
St Louis, Missouri, 63110
Site Ref # / Investigator 10202
Towson, Maryland, 21204
Site Ref # / Investigator 6687
Winter Park, Florida, 32789
Site Ref # / Investigator 6667
Zephyrhills, Florida, 33542

Other trials in United States

Canada16 sites

Site Ref # / Investigator 9422
Calgary, Alberta, T2N 4Z6
Site Ref # / Investigator 14042
Edmonton, Alberta, T6G 2X8
Site Ref # / Investigator 7596
Halifax, Nova Scotia, B3H 2Y9
Site Ref # / Investigator 7641
Hamilton, Ontario, L8N 3Z5
Site Ref # / Investigator 10681
London, Ontario, N6A 5K8
Site Ref # / Investigator 7629
Montreal, Quebec, H1T 2M4
Site Ref # / Investigator 14702
Montreal, Quebec, H3A 1A1
Site Ref # / Investigator 15061
Montreal, Quebec, H3T 1E2
Site Ref # / Investigator 17881
Québec, Quebec, G1R 2J6
Site Ref # / Investigator 7642
Saskatoon, Saskatchewan, S7K 1N4
Site Ref # / Investigator 14821
Saskatoon, Saskatchewan, S7N 0W8
Site Ref # / Investigator 7634
St. John's, Newfoundland and Labrador, A1B - 3V6
Site Ref # / Investigator 17901
Toronto, Ontario, M5G 1X5
Site Ref # / Investigator 7630
Truro, Nova Scotia, B2N 1L2
Site Ref # / Investigator 7610
Vancouver, British Columbia, V6Z-2K5
Site Ref # / Investigator 8206
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Denmark3 sites

Site Ref # / Investigator 16985
Herlev, DK-2730
Site Ref # / Investigator 16235
Hvivdovre, 2650
Site Ref # / Investigator 16234
Odense C, 5000

Other trials in Denmark

Belgium2 sites

Site Ref # / Investigator 16230
Bonheiden, 2820
Site Ref # / Investigator 16231
Leuven, 3000

Other trials in Belgium

Puerto Rico2 sites

Site Ref # / Investigator 10961
Ponce, 00717
Site Ref # / Investigator 16801
San Juan, 00935

Other trials in Puerto Rico

Australia1 site

Site Ref # / Investigator 16983
Box Hill, Victoria, 3128

Other trials in Australia

Austria1 site

Site Ref # / Investigator 16225
Vienna, 1090

Other trials in Austria

About this study

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.

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
Being tested: Placebo, ABT-874
Keywords: Crohn's Disease
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboBiological
every 4 weeks, IV
ABT-874Biological
400 mg IV every 4 weeks
ABT-874Biological
700 mg IV every 4 weeks

Study groups in NCT00562887
Study group	Role	What they receive
1	Placebo comparator	Not described Receives: Biological: Placebo
400 mg	Experimental	Not described Receives: Biological: ABT-874
700mg	Experimental	Not described Receives: Biological: ABT-874

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Measured: Week 6

Secondary outcomes (1)

Patient reported outcomes, clinical response indicators, safety parameters
Measured: Weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Apr 2010

First posted26 Nov 2007 (estimated)
Study startNov 2007
Primary completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00562887
Sponsor's protocol ID: M10-222
Other IDs: 2008-004919-36, 2008
Status last verified: Aug 2011
First submitted: 21 Nov 2007
Last updated: 23 Aug 2011
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
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Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
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Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
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Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00562887
Acronym / sponsor ID: M10-222
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 246 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Apr 2010 (actual)
First posted: 26 Nov 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Placebo comparator	Biological: Placebo
400 mg	Experimental	Biological: ABT-874
700mg	Experimental	Biological: ABT-874

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placeboevery 4 weeks, IV	Biological	1
ABT-874400 mg IV every 4 weeks	Biological	400 mg
ABT-874700 mg IV every 4 weeks	Biological	700mg

Primary outcome

Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Time frame: Week 6

1 secondary outcome

Patient reported outcomes, clinical response indicators, safety parameters
Time frame: Weeks 12 and 24

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.

Related trials for Crohn's Disease

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roberto Carcereri, MD study director

Abbott

61 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-874 in people with Crohn's Disease, run by Abbott at 61 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Canada, Denmark, Belgium, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00562887.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.