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Completed

NCT Number: NCT01145352

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

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yokohama City University School of

Tokyo, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept (genetical recombination)

Drug

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).

Other names: Enbrel

Primary outcomes

  1. Number of Participants With Treatment-Related Adverse Events of Etanercept

    Time frame: 24 weeks

    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.

  2. Number of Participants With Serious Treatment-Related Adverse Events of Etanercept

    Time frame: 24 weeks

    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.

  3. Number of Unlisted Treatment-Related Adverse Events of Etanercept

    Time frame: 24 weeks

    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.

  4. Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Percentage of Participants With Overall Improvement On Physician's Assessment.

    Time frame: 24 weeks

    Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: Enbrel-JIA

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2010
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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