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Treatment for Subjects With Active Rheumatoid Arthritis (RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00110903
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : April 26, 2013
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Etanercept Liquid Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.

Secondary Outcome Measures :
  1. Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes
  2. Measurements from safety laboratory assessments.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate:

  • AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL;
  • Platelet count greater than or equal to 125,000/cm3;
  • White blood cell count (WBC) greater than or equal to 3500 cells/cm3;
  • Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110903

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00110903     History of Changes
Other Study ID Numbers: 20020378
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Amgen:
Rheumatoid arthritis

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