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Terminated/Withdrawn
Sponsor ID
20120125

Evaluating Etanercept Use in Patients with Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to AdalimumabROCkIES

Sponsor ID
20120125
Clinicaltrials.gov ID
NCT01927757
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
90
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the efficacy of etanercept in adult subjects with moderate to severe rheumatoid arthritis who failed to respond or responded and then lost response to adalimumab as first biologic agent.

Timeframe: 12 weeks

Secondary Outcome Measures

Determine if anti-adalimumab antibodies predict response to etanercept, to determine if adalimumab failures predict response to etanercept, and to evaluate the effects of etanercept

Timeframe: weeks 12 and 24

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Montreal, QC, Canada, H2L 1S6
Status
Completed
Location
Research Site
Austin, TX, United States, 78731
Status
Completed
Location
Research Site
Caguas, PR, United States, 00725
Status
Completed
Location
Research Site
Charlotte, NC, United States, 28210
Status
Completed
Location
Research Site
Clarksburg, WV, United States, 26301
Status
Completed
Location
Research Site
Corpus Christi, TX, United States, 78404
Status
Completed
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Study Info
Age
18+ years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    May 2013 - Jun 2015
    Inclusion and Exclusion 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