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Completed

NCT Number: NCT01230177

Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases Rheumatoid

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taihaku Sakura Hospital

Sendai, Miyagi, 982-0032, Japan

About this study

Implemented as a Special Investigation by Central Registration System

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients need to be administered etanercept in order to be enrolled in the survey
  • Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion criteria

  • Patients who have been administered etanercept 50mg once a week
  • Patients who have been administered etanercept 25mg once a week

Treatment and study plan

etanercept (genetical recombination)

Drug

10 to 25 mg of etanercept (genetical recombination) reconstituted in 1 mL of water for injection (JP) administered twice weekly as a subcutaneous injection or 25 to 50 mg of etanercept (genetical recombination) administered once weekly as a subcutaneous injection, are usually the recommended dose for adults.

Other names: Enbrel

Primary outcomes

  1. Number of Participants With Treatment Related Adverse Events

    Time frame: 12 weeks

    Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.

  2. Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])

    Time frame: 12 weeks

    DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

    DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

  3. Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])

    Time frame: 12 weeks

    DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

    DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

Secondary outcomes

  1. Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values

    Time frame: 12 weeks

    On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2010
Registry last updated
Feb 23, 2017

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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