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

NCT00195403 | Completed Results

• 1 other identifier: 0881A-101575
• Study Type: observational
• Target: 1,014
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.

  Baseline up to Day 832

• Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3

  PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.

  Baseline, Month 3

Secondary Outcomes (1)

• Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9

  Baseline, Month 3, 9

Study Arms (1)

1

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept 25mg Injection, 2 times/week

1

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, secondary and tertiary medical centers

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Unknown Facility

Kyunggi-do, 463-712, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 133-792, South Korea

Location

Unknown Facility

Seoul, 137-807, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 15, 2013
• Results First Posted: August 15, 2013

Record last verified: 2013-06

Locations

KR (4)