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Trial record 1 of 1 for:    NCT01230177
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Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01230177
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 27, 2010
First Posted Date October 28, 2010
Results First Submitted Date March 27, 2014
Results First Posted Date February 23, 2017
Last Update Posted Date February 23, 2017
Study Start Date May 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: October 27, 2010)
  • The incidence of adverse events [ Time Frame: 12 weeks ]
  • Adverse events not expected from Japanese Package Insert (unknown adverse events) [ Time Frame: 12 weeks ]
  • Score of DAS28-4ER (amount of change) [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2017)
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.
Original Secondary Outcome Measures
 (submitted: October 27, 2010)
overall improvement scale (assessed by physician) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
Brief Summary 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.
Detailed Description Implemented as a Special Investigation by Central Registration System
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
Condition
  • Arthritis
  • Rheumatoid
Intervention Drug: etanercept (genetical recombination)
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 Name: Enbrel
Study Groups/Cohorts Etanercept (genetical recombination)
Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
Intervention: Drug: etanercept (genetical recombination)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2013)
3
Original Estimated Enrollment
 (submitted: October 27, 2010)
30
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01230177
Other Study ID Numbers B1801134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2017