Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Lead Sponsor:
Amgen
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.
Detailed Description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Eligibility Criteria
Inclusion
- Key
- moderate to severe Crohn's Disease
- CDAI 250-450
- CRP \>7.5
- signed written informed consent
- Key
Exclusion
- \> 100 cm of small bowel resected
- ileostomy, colostomy or rectal pouch
- diagnosis of ulcerative colitis or indeterminate colitis
- evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
- hepatitis B, C or HIV infection
- history of infection requiring IV antibiotics
- serious or GI infection in the previous 12 weeks
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT00306215
Start Date
March 1 2006
End Date
June 1 2009
Last Update
March 6 2025
Active Locations (112)
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1
Bankstown - Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
2
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia, 4029
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia
4
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042