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A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00195403
First received: September 12, 2005
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation.

  1. Unknown adverse reactions, especially serious adverse reactions
  2. Incidences of adverse reactions under routine drug uses
  3. Factors that may affect the safety of the drug
  4. Factors that may affect the efficacy of the drug

This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Etanercept
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Drug Use Investigation of Enbrel for Post-Marketing Surveillance

Resource links provided by NLM:

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

Further study details as provided by Pfizer:

Enrollment: 487
Study Start Date: May 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: Etanercept
Etanercept 25mg Injection, 2 times/week

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic, secondary and tertiary medical centers

Criteria

Inclusion Criteria

Rheumatoid Arthritis

  • Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate
  • Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX

Psoriatic Arthritis

- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs

Exclusion Criteria

  • Patients to whom Enbrel is contraindicated as per the local labeling
  • Patients with known hypersensitivity to Enbrel or any component of the product
  • Patients with sepsis or risk of sepsis
  • Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195403

Locations
Korea, Republic of
Kyunggi-do, Korea, Republic of, 463-712
Seoul, Korea, Republic of, 137-807
Seoul, Korea, Republic of, 133-792
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00195403     History of Changes
Other Study ID Numbers: 0881A-101575
Study First Received: September 12, 2005
Last Updated: March 27, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pfizer:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System 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 19, 2013