Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab (ROCkIES)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 5, 2013
Last updated: January 21, 2016
Last verified: January 2016
This study will evaluate effectiveness of etanercept with the use of 20% improvement criteria (ACR20) measured at week 12 in adults with moderate to severe Rheumatoid Arthritis. Subjects will either have failed to respond or lost satisfactory response to adalimumab, when used as their first biologic agent, in order to qualify for the study. Subject will take a stable dose of methotrexate during study (subject had to have been taking for at least 12 weeks and a stable dose of 15 mg per week for 8 weeks.)

Condition Intervention Phase
Moderate to Severe Rheumatoid Arthritis
Biological: etanercept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Amgen:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Will use American College of Rheumatology 20% improvement criteria (ACR20)

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 [ Time Frame: weeks 12 and 24 ] [ Designated as safety issue: No ]
    presence or absence of anti-adalimumab antibodies in blood draw, and defined by ACR20 at week 12; the effect of etanercept using ACR20, ACR50, ACR70 and DAS 28-C-Reactive Protein at wks 12 and 24

Enrollment: 90
Study Start Date: May 2013
Study Completion Date: August 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: etanercept
etanercept 50 mg administered subcutaneously 1 dose per week for 24 weeks
Biological: etanercept
Etanercept is a protein containing extracellular domains of 2 TNF receptors. It is able to bind both TNF alpha and TNF beta and thus acts primarily by binding and neutralizing both soluble and cell-bound TNF alpha. TNF alpha is a naturally occurring cytokine that is involved with normal inflammatory and immune responses. Elevated levels of TNF are found in involved tissues and fluids of rheumatoid arthritis patients. Etanercept inhibits TNF alpha activity.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01927757

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Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01927757     History of Changes
Other Study ID Numbers: 20120125 
Study First Received: June 5, 2013
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
rheumatoid arthritis
adalimumab failure to respond
loss of response to adalimumab
Swollen joints
tender joints

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016