Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
NCT00195338
Last updated date
ABOUT THIS STUDY
The purpose of the study is to determine the long term safety of Enbrel in adults with active
rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in
rheumatology practice patients. All patients initiated with Enbrel will be observed from the
start of the study in Feb 2003 for a period of at least 5 years.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
17 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Have moderate to severe active rheumatoid arthritis
- Be aged of 17 years or more
- Have inadequate response to DMards
- Give written informed consent
- Physician decides to prescribe Enbrel
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
n/a
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg | |||
| Official Title | A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg | |||
| Brief Summary | The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | Patients will be included after the physician decided to prescribe Enbrel. | |||
| Condition | Rheumatoid Arthritis | |||
| Intervention | Drug: etanercept | |||
| Study Groups/Cohorts | 1
This is an open label, observational study.This is a post-marketing surveillance study in rheumatology practice patients in Luxemburg.Rheumatologists will be asked to document safety and adherence to therapy of Enbrel when given to adults with active rheumatoid arthritis.All patients initiated with Enbrel will be observed. Intervention: Drug: etanercept | |||
| 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 | Completed | |||
| Actual Enrollment | 25 | |||
| Original Enrollment | 50 | |||
| Actual Study Completion Date | December 2010 | |||
| Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: n/a | |||
| Sex/Gender |
| |||
| Ages | 17 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Luxembourg | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00195338 | |||
| Other Study ID Numbers | 0881-101343 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Innovex, Inc | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2011 | |||