NCT01012570

Brief Summary

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

  • Trial with medicinal product

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

November 11, 2009

Last Update Submit

December 3, 2014

Conditions

Interventions

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients cohort of the University Hospital Zurich

You may qualify if:

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

You may not qualify if:

  • other TNF-Blocker
  • Steroids \> 40 mg
  • Malignoma in der Anamnesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.Dr.Dr. gerhard Rogler

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 13, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations