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

This study has been terminated.
(not enough patients enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012570
First Posted: November 13, 2009
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich
  Purpose

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

  • Trial with medicinal product

Condition Intervention Phase
Crohn's Disease Drug: Application of Adalimumab Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Gerhard Rogler, University of Zurich:

Enrollment: 34
Study Start Date: August 2009
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Application of Adalimumab
    Adalimumab will be applied according to manufacture's instruction and official guidelines.
  Eligibility

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
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

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 Submitted: November 11, 2009
First Posted: November 13, 2009
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