Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

Juvenile Idiopathic Arthritis Clinical Trial

— Enbrel-JIA  

Official title:

Enbrel-JIA Use Results Survey [All-Case Surveillance]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145352
• Other study ID #: 0881Y1-4689
• Secondary ID: B1801130
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: August 20, 2014
• Start date: July 2009
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.

1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events

2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

Description:

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).

• Patients receiving Enbrel for JIA as diagnosed by a qualified physician.

• Age 5 - 16 years

Exclusion Criteria:

• Patients not administered ENBREL

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Etanercept (genetical recombination)
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).

Locations

Country	Name	City	State
Japan	Yokohama City University School of	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events of Etanercept	Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.	24 weeks	Yes
Primary	Number of Participants With Serious Treatment-Related Adverse Events of Etanercept	Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.	24 weeks	Yes
Primary	Number of Unlisted Treatment-Related Adverse Events of Etanercept	Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.	24 weeks	Yes
Primary	Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28	The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.	24 weeks	No
Secondary	Percentage of Participants With Overall Improvement On Physician's Assessment.	Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.	24 weeks	No

External Links

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