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

This study has been terminated.

(not enough patients enrolled)

Sponsor:

Information provided by (Responsible Party):

Gerhard Rogler, University of Zurich

ClinicalTrials.gov Identifier:

NCT01012570

First received: November 11, 2009

Last updated: December 3, 2014

Last verified: December 2014

History of Changes

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by 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:

Adalimumab will be applied according to manufacture's instruction and official guidelines.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012570

Locations


Switzerland

Zurich, Switzerland

Sponsors and Collaborators

Gerhard Rogler

Investigators


Study Director:	01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich

More Information

No publications provided


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
Study First Received:	November 11, 2009
Last Updated:	December 3, 2014
Health Authority:	Switzerland: Swissmedic

Additional relevant MeSH terms:


Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases	Adalimumab Anti-Inflammatory Agents Antirheumatic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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