Clinical trial NCT01927757: Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
Official title: A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Moderate to Severe Rheumatoid Arthritis
Keywords: rheumatoid arthritis
etanercept
arthritis
adalimumab failure to respond
loss of response to adalimumab
ACR20
methotrexate
Swollen joints
tender joints
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months
* Active RA with at least 3 swollen and tender joints
* Failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug)
* Negative for hepatitis B and C
* Negative serum and urine pregnancy tests before starting study
* currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability
* Normal chest X-ray within 3 months
* Negative testing for tuberculosis (TB)

Exclusion Criteria:

* Class IV RA (wheel-chair or bed-bound)
* Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than RA, Multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease)
* Other inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an ACR 20 Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an ACR 50 Response at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Percentage of Participants With an ACR 70 Response at Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)
timeFrame: Baseline and weeks 12 and 24
measure: Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline
timeFrame: Baseline and weeks 12 and 24
measure: Percentage of Participants With DAS 28-CRP < 3.2
timeFrame: Weeks 12 and 24
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline and weeks 12 and 24
measure: Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24
timeFrame: Baseline and Week 24
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline, week 12 and week 24
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Covina
country: United States
facility: Research Site
state: California
city: Hemet
country: United States
facility: Research Site
state: California
city: Murrieta
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Victorville
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Dunedin
country: United States
facility: Research Site
state: Florida
city: Largo
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Bowling Green
country: United States
facility: Research Site
state: Kentucky
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Fall River
country: United States
facility: Research Site
state: Massachusetts
city: Battle Creek
country: United States
facility: Research Site
state: Michigan
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Smithtown
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Middleburg Heights
country: United States
facility: Research Site
state: Ohio
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Hixson
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Victoria
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Clarksburg
country: United States
facility: Research Site
state: West Virginia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Quispamsis
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec City
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Caguas
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bessette L, Khraishi M, Kivitz AJ, Kaliyaperumal A, Grantab R, Poulin-Costello M, Isaila M, Collier D. Single-Arm Study of Etanercept in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment. Rheumatol Ther. 2017 Dec;4(2):391-404. doi: 10.1007/s40744-017-0079-x. Epub 2017 Sep 12.