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The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients

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ClinicalTrials.gov Identifier: NCT01012570
Recruitment Status : Terminated (not enough patients enrolled)
First Posted : November 13, 2009
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich

Study Description
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Brief Summary:

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

  • Trial with medicinal product

Condition or disease Intervention/treatment
Crohn's Disease Drug: Application of Adalimumab

Study Design
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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : August 2009
Actual Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources

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

Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients cohort of the University Hospital Zurich
Criteria

Inclusion criteria:

  • CDAI > 220 und < 450
  • Biologika naiv
  • CD seit > 6 Monaten

Exclusion criteria:

  • other TNF-Blocker
  • Steroids > 40 mg
  • Malignoma in der Anamnesis
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012570


Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Gerhard Rogler
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Gerhard Rogler, Prof.Dr.Dr. gerhard Rogler, University of Zurich
ClinicalTrials.gov Identifier: NCT01012570     History of Changes
Other Study ID Numbers: HUM-07-019
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents