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Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.

Clinical Details

Official title: A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade (Infliximab)

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.

Secondary outcome:

Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.

Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16

Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.

Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16

Subject incidence rate of SAEs over 16 weeks

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults with RA (ACR criteria) for greater than or equal to 6 months

- Infliximab treatment for at least 18 weeks

- Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every

4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)

- Failing infliximab defined by ALL of the following at screening and baseline visit:

Disease Activity Score (DAS 28) greater than or equal to 4. 5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints

- Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or

equal to 10 mg/week at least 10 weeks prior to screening

- Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including

sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening

- Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks

prior to screening

- Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to

1 week prior to screening

Exclusion Criteria:

- ACR functional class IV - Prior treatment with etanercept

- Receipt of any investigational drug/biologic within 28 days of study drug initiation

- Active infection or predisposition to infection

- Elective surgery planned during study period

- Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4

weeks prior to screening

- Contraindications to etanercept as defined in the package insert

- Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV

congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis

Locations and Contacts

Research Site, Montgomery, Alabama, United States

Research Site, Huntsville, Alabama, United States

Research Site, Scottsdale, Arizona, United States

Research Site, Paradise Valley, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Long Beach, California, United States

Research Site, Los Angeles, California, United States

Research Site, Upland, California, United States

Research Site, Hamden, Connecticut, United States

Research Site, Jupiter, Florida, United States

Research Site, Delray Beach, Florida, United States

Research Site, Clearwater, Florida, United States

Research Site, S Miami, Florida, United States

Research Site, Boise, Idaho, United States

Research Site, Coeur d'Alene, Idaho, United States

Research Site, Meridian, Idaho, United States

Research Site, Rockford, Illinois, United States

Research Site, Chicago, Illinois, United States

Research Site, Louisville, Kentucky, United States

Research Site, Columbia, Maryland, United States

Research Site, St. Clair Shores, Michigan, United States

Research Site, Lansing, Michigan, United States

Research Site, Saint Paul, Minnesota, United States

Research Site, Duluth, Minnesota, United States

Research Site, St. Louis, Missouri, United States

Research Site, St Louis, Missouri, United States

Research Site, Lebanon, New Hampshire, United States

Research Site, Manalapan, New Jersey, United States

Research Site, New Brunswick, New Jersey, United States

Research Site, Mercerville, New Jersey, United States

Research Site, Plainview, New York, United States

Research Site, Hewlett, New York, United States

Research Site, New York, New York, United States

Research Site, Syracuse, New York, United States

Research Site, Gastonia, North Carolina, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Toronto, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, Duncansville, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Wexford, Pennsylvania, United States

Research Site, Colmar, Pennsylvania, United States

Research Site, Reckledge, Pennsylvania, United States

Research Site, Bethlehem, Pennsylvania, United States

Research Site, Montreal, Quebec, Canada

Research Site, Charleston, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Midland, Texas, United States

Research Site, Carrollton, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Arlington, Virginia, United States

Research Site, Edmonds, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, Racine, Wisconsin, United States

Additional Information

AmgenTrials clinical trials website

Starting date: May 2004
Last updated: May 30, 2008

Page last updated: June 20, 2008

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