World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01783015
Date of registration: 31/01/2013
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate SERUM
Scientific title: 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
Date of first enrolment: September 2013
Target sample size: 16
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01783015
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Australia Belgium France Hong Kong Israel Netherlands Russian Federation Spain
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Etanercept
Drug: Placebo
Primary Outcome(s)
Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12. [Time Frame: Baseline, 12 weeks]
Secondary Outcome(s)
Change From Baseline in CDAI [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in CRP [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D) [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI) [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Number of Swollen Joints [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Number of Tender/Painful Joints [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Patient Acceptable Symptom State (PASS) [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Physician Global Assessment of Disease Activity [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in SDAI. [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Short Form-36 Health Survey (SF-36) [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Subject General Health VAS. [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Subject Global Assessment of Disease Activity [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in Subject Pain [Time Frame: Baseline, 12 weeks, 24 weeks]
Change From Baseline in the DAS28 at Week 24 [Time Frame: Baseline, 24 weeks]
Change From Baseline in Vectra Disease Activity Levels [Time Frame: Baseline, 12 weeks, 24 weeks]
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Time Frame: 12 weeks, 24 weeks]
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Time Frame: 12 weeks, 24 weeks]
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Time Frame: 12 weeks, 24 weeks]
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response [Time Frame: 12 weeks, 24 weeks]
Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response. [Time Frame: 12 weeks, 24 weeks]
Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI) [Time Frame: 12 weeks, 24 weeks]
Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI). [Time Frame: 12 weeks, 24 weeks]
Number of Participants With DAS28 <2.6 [Time Frame: 12 weeks, 24 weeks]
Number of Participants With DAS28 <3.2 [Time Frame: 12 weeks, 24 weeks]
Number of Participants With Positive Etanercept Anti-drug Antibody Status [Time Frame: Baseline, 12 weeks, 24 weeks]
Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status [Time Frame: Baseline, 12 weeks, 24 weeks]
Secondary ID(s)
2012-003644-71
B1801355
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 06/01/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01783015
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history