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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01927757
First received: June 5, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Estimated Enrollment: 250
Study Start Date: May 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2016 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 44 Study Locations
Sponsors and Collaborators
Amgen
Investigators
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: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
rheumatoid arthritis
etanercept
arthritis
adalimumab failure to respond
loss of response to adalimumab
ACR20
methotrexate
Swollen joints
tender joints

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

ClinicalTrials.gov processed this record on September 18, 2014