Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 16, 2007
Last updated: February 14, 2014
Last verified: February 2014
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.

Condition Intervention
Rheumatoid Arthritis
Drug: Enbrel (etanercept)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Term Safety and Efficacy From Special Surveillance for Etanercept in Japan

Resource links provided by NLM:

Further study details as provided by Pfizer:

Enrollment: 684
Study Start Date: June 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Enbrel (etanercept)
    Enbrel 10 to 25 mg twice a week subcutaneous injection

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital and Rheumatology clinic

Inclusion Criteria:

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.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00503139

Pfizer Investigational Site
Sapporo, Japan
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00503139     History of Changes
Other Study ID Numbers: 0881A1-4426 
Study First Received: July 16, 2007
Last Updated: February 14, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on May 05, 2016