The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.
Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following
1. Patients who are refractory to the treatment.
2. Patients who have never been treated with Enbrel and in whom its long-term therapy may
be instituted.
3. Patients without a history of or concurrent malignant tumors.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan | |||
| Official Title | Enbrel Special Use Result Surveillance | |||
| Brief Summary | The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Hospital and Rheumatology clinic | |||
| Condition | Rheumatoid Arthritis | |||
| Intervention | Drug: Enbrel (etanercept) Enbrel 10 to 25 mg twice a week subcutaneous injection | |||
| Study Groups/Cohorts | 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 | Completed | |||
| Actual Enrollment | 684 | |||
| Original Enrollment | Not Provided | |||
| Actual Study Completion Date | April 2013 | |||
| Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria: Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following
Exclusion Criteria: | |||
| Sex/Gender |
| |||
| Ages | 10 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 | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00503139 | |||
| Other Study ID Numbers | 0881A1-4426 B1801045 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2017 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
