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

Amgen

Status and phase

Terminated

Phase 4

Conditions

Moderate to Severe Rheumatoid Arthritis

Treatments

Biological: Etanercept

Drug: Methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01927757

20120125

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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