Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01230177
First received: October 27, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.


Condition Intervention Phase
Arthritis
Rheumatoid
 Drug: etanercept (genetical recombination)
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events not expected from Japanese Package Insert (unknown adverse events) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Score of DAS28-4ER (amount of change) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall improvement scale (assessed by physician) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Etanercept (genetical recombination)
Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
 Drug: etanercept (genetical recombination)
10 to 25 mg of etanercept (genetical recombination) reconstituted in 1 mL of water for injection (JP) administered twice weekly as a subcutaneous injection or 25 to 50 mg of etanercept (genetical recombination) administered once weekly as a subcutaneous injection, are usually the recommended dose for adults.
Other Name: Enbrel

Detailed Description:

Implemented as a Special Investigation by Central Registration System

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230177

Locations
Japan
Taihaku Sakura Hospital
Sendai, Miyagi, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01230177     History of Changes
Other Study ID Numbers: B1801134
Study First Received: October 27, 2010
Last Updated: May 14, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013