You are here

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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
RK Will Pty Ltd
Victoria Park, Western Australia, 6100 Australia
Contact
1-800-718-1021
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.

NCT01783015
Pfizer
Terminated
Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Psoriatic Arthritis
NCT01976364
All Genders
18+
Years
Multiple Sites
Arthritis Juvenile Idiopathic
NCT03000439
All Genders
2+
Years
Multiple Sites
Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Etanercept
    Etanercept 50 mg once-weekly
  • Drug: Placebo
    Etanercept placebo once-weekly
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
August 2014
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Hong Kong,   Israel,   Russian Federation,   Spain
Netherlands
 
NCT01783015
B1801355
2012-003644-71 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now