Chlorpheniramine, Hydrocodone and Phenylephrine Liquid |
Atuss HD; Atuss MS Liquid; Atuss-HC; Comtussin HC Syrup; Cytuss HC Liquid; Endagen-HD Liquid; Endal HD Plus; Histinex HC Syrup; Histussin HC Syrup; Hydro PC II Liquid; Hydro PC Liquid; Hydron CP; Maxi-Tuss HC Liquid; Poly-Tussin; Relacon HC Liquid; Vanex HD; Z-Cof HC |
Clinical Trial: Treatment for Subjects with Active Rheumatoid Arthritis (RA)
This study is no longer recruiting patients.
|
Purpose
The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: Etanercept Liquid | Phase III |
MedlinePlus related topics: Rheumatoid Arthritis
Study Type: Interventional
Study Design: Treatment, Open Label, Safety/Efficacy Study
Official Title: Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects with Active Rheumatoid Arthritis (RA)
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
More Information
AmgenTrials clinical trials website
CenterWatch Clinical Trials Listing Service
Record last reviewed: May 2005
Last Updated: May 16, 2005
Record first received: May 16, 2005
ClinicalTrials.gov Identifier: NCT00110903
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17
Source: ClinicalTrials.gov
Cache Date: May 18, 2005
Resources
- Atuss HD (Drug Digest)
- Atuss MS Liquid (Drug Digest)

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