Terminated/Withdrawn
Sponsor ID
20100008

Safety Study in Subjects With Crohn's Disease

Sponsor ID
20100008
Clinicaltrials.gov ID
NCT01199302
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This study is an open label extension of study 20090072 with subjects with Crohn's disease. Subjects will receive 350 mg AMG 827 intraveneously every 4 weeks for approximately 2 and a half years. The study will be evaluated for safety and efficacy of AMG 827.

Additional Study Details

Phase
Phase 2
Product
AMG 827
Type
Interventional
Masking
None (Open Label)
Enrollment
67
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and Crohn’s Disease Activity Index (CDAI). To evaluate the maintenance of effect as measured by the HBI and CDAI

Timeframe: 2 1/2 years

To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn’s disease.

Timeframe: 2 1/2 years

Secondary Outcome Measures

To determine if subjects develop anti-AMG 827 antibodies; to evaluate the change of EQ-5D from baseline at all timepoints, the effect of treatment on inflammatory markers (C-reactive protein [CRP]) at post-base, and the pharmacokinetics of AMG 827.

Timeframe: 2 1/2 years

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Box Hill, VIC, Australia, 3128
Status
Recruiting
Location
Research Site
Kurralta Park, SA, Australia, 5037
Status
Recruiting
Location
Research Site
Fremantle, WA, Australia, 6160
Status
Recruiting
Location
Research Site
Fitzroy, VIC, Australia, 3065
Status
Recruiting
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
Gent, Belgium, 9000
Status
Recruiting
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