Treatment for Subjects With Active Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00110903
• Date of registration: 16/05/2005
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Treatment for Subjects With Active Rheumatoid Arthritis (RA)
• Scientific title: Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)
• Date of first enrolment: May 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00110903
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept Liquid

Primary Outcome(s)

Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.

Secondary Outcome(s)

Measurements from safety laboratory assessments.

Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes

Secondary ID(s)

20020378

Source(s) of Monetary Support

Please refer to primary and secondary sponsors