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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01012570
Other study ID # HUM-07-019
Secondary ID
Status Terminated
Phase Phase 2
First received November 11, 2009
Last updated December 3, 2014
Start date August 2009

Study information

Verified date December 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

The investigators will study the effect of Adalimumab on the bone microstructure.

- Trial with medicinal product


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion criteria:

- CDAI > 220 und < 450

- Biologika naiv

- CD seit > 6 Monaten

Exclusion criteria:

- other TNF-Blocker

- Steroids > 40 mg

- Malignoma in der Anamnesis

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Application of Adalimumab
Adalimumab will be applied according to manufacture's instruction and official guidelines.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gerhard Rogler

Country where clinical trial is conducted

Switzerland, 

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