Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

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NCT01783015

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Study Location
RK Will Pty Ltd
Victoria Park, Western Australia, 6100, Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Met the 1987 ACR Revised Criteria for RA

2. A history of inadequate response to infliximab or adalimumab in combination with methotrexate.

3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. ACR functional class IV


2. Prior treatment with etanercept; both infliximab and adalimumab; or any
immunosuppressive biologic agent other than infliximab or adalimumab.


3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate
efficacy response.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate
Brief Summary The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.
Detailed Description This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etanercept
    Etanercept 50 mg once-weekly
  • Drug: Placebo
    Etanercept placebo once-weekly
Study Arms  ICMJE
  • Experimental: Group A
    Subjects who are mAb ADA positive
    Intervention: Drug: Etanercept
  • Experimental: Group B
    Subjects who are mAb ADA negative
    Intervention: Drug: Etanercept
  • Placebo Comparator: Group C
    Subjects who are mAb ADA positive
    Intervention: Drug: Placebo
  • Placebo Comparator: Group D
    Subjects who are mAb ADA negative
    Intervention: Drug: Placebo
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  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 22, 2014)		16
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2013)		168
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Met the 1987 ACR Revised Criteria for RA
  2. A history of inadequate response to infliximab or adalimumab in combination with methotrexate.
  3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

Exclusion Criteria:

  1. ACR functional class IV
  2. Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.
  3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   France,   Hong Kong,   Israel,   Russian Federation,   Spain
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01783015
Other Study ID Numbers  ICMJE B1801355
2012-003644-71 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP