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
  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 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

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 July 29, 2015