Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 June 2013
• Main ID: NCT01230177
• Date of registration: 27/10/2010
• Primary sponsor: Pfizer
• Public title: Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
• Scientific title: Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
• Date of first enrolment: November 2010
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01230177
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

Japan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients need to be administered etanercept in order to be enrolled in the survey

- Patients who have changed regimen from 10 mg twice a week administration to 25 mg
once a week administration.

Exclusion Criteria:

- Patients who have been administered etanercept 50mg once a week

- Patients who have been administered etanercept 25mg once a week



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis

Rheumatoid

Intervention(s)

Drug: etanercept (genetical recombination)

Primary Outcome(s)

Adverse events not expected from Japanese Package Insert (unknown adverse events) [Time Frame: 12 weeks]

Score of DAS28-4ER (amount of change) [Time Frame: 12 weeks]

The incidence of adverse events [Time Frame: 12 weeks]

Secondary Outcome(s)

overall improvement scale (assessed by physician) [Time Frame: 12 weeks]

Secondary ID(s)

B1801134

Source(s) of Monetary Support

Please refer to primary and secondary sponsors