CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
This study is currently recruiting participants.
Verified March 2012 by Elan Pharmaceuticals
Sponsor:
Elan Pharmaceuticals
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00707512
First received: June 27, 2008
Last updated: March 15, 2012
Last verified: March 2012
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 27, 2008 |
| Last Updated Date | March 15, 2012 |
| Start Date ICMJE | June 2008 |
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Incidence of serious and/or clinically significant infections, malignancies, and other SAEs in patients with CD treated with TYSABRI® |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00707512 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Disease severity over time in CD patients treated with TYSABRI®. |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring |
| Official Title ICMJE | Investigating Natalizumab Through Further Observational Research and Monitoring |
| Brief Summary | The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients with Crohn's Disease(CD) treated with TYSABRI® (Natalizumab) |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Specialty IBD clinics or GI clinical practices |
| Condition ICMJE | Crohn's Disease |
| Intervention ICMJE | Drug: Natalizumab
This is an observational study to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse events in Crohn's disease patients treated with commercial Tysabri (Natalizumab). There is no additional drug administration during this observational study. |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 2000 |
| Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00707512 |
| Other Study ID Numbers ICMJE | ELN100226-CD451, CD INFORM |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Elan Pharmaceuticals |
| Study Sponsor ICMJE | Elan Pharmaceuticals |
| Collaborators ICMJE | Biogen Idec |
| Investigators ICMJE | Not Provided |
| Information Provided By | Elan Pharmaceuticals |
| Verification Date | March 2012 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|