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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01696396
Date of registration: 27/09/2012
Prospective Registration: Yes
Primary sponsor: Amgen
Public title: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
Date of first enrolment: December 4, 2012
Target sample size: 254
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01696396
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
Austria Belgium Canada Czech Republic Czechia Denmark France Germany
Hungary Netherlands Switzerland United Kingdom United States
Contacts
Name:     MD
Address: 
Telephone:
Email:
Affiliation:  Amgen
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6
months prior to baseline

- Moderately to severely active Crohn's disease defined by a CDAI score = 220 and = 450
at baseline

- Evidence of active inflammation within 12 weeks prior to baseline

- Demonstrated an inadequate response to, loss of response to, or intolerance to at
least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor
(TNF) agents or to corticosteroids (non-US sites only).

- Neurological exam free of clinically significant, unexplained signs or symptoms during
screening and no clinically significant change prior to randomization

- Subject has no known history of active tuberculosis and has a negative test for
tuberculosis during screening

Exclusion Criteria:

- Short bowel syndrome

- Stricture with obstructive symptoms within 3 months

- Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24
weeks from baseline

- Ileostomy and/or colostomy

- Any gastric or intestinal pouch

- Evidence of an infected abscess

- Bowel perforation or evidence of non-inflammatory obstruction during the 6 months
prior to baseline

- Stool positive for C. difficile toxin at screening

- Any uncontrolled or clinically significant systemic disease

- Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus
antibody, or human immunodeficiency virus (HIV)

- Any underlying condition that predisposes subject to infections

- Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell
carcinoma, or treated in situ cervical cancer considered cured) within 5 years of
baseline

- Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus
(rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg,
mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids
within protocol-specified time periods.

- Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab,
efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any
form of cell-based transplantation

- Received treatment of infection with intravenous (within 30 days of baseline) or oral
(within 14 days prior to baseline) antibiotics, antivirals, or antifungals

- Significant laboratory abnormalities

- Pregnant or breast feeding



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Abrilumab
Drug: Placebo
Primary Outcome(s)
Percentage of Participants With Remission at Week 8 [Time Frame: Week 8]
Secondary Outcome(s)
Change From Baseline in CDAI Score at Week 12 [Time Frame: Baseline and week 12]
Change From Baseline in CDAI Score at Week 8 [Time Frame: Baseline and week 8]
Percentage of Participants With Remission at Week 12 [Time Frame: Week 12]
Percentage of Participants With Response at Week 12 [Time Frame: Baseline and week 12]
Percentage of Participants With Response at Week 8 [Time Frame: Baseline and week 8]
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24 [Time Frame: Week 12 and week 24]
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24 [Time Frame: Week 8 and week 24]
Secondary ID(s)
20110232
2012-000529-31
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 27/06/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01696396
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