Status:
WITHDRAWN
A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not receive...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female subject age 18 years or older
- Diagnosis of RA
- Disease duration of ≥ 6 months and ≤ 2 years
- Active disease at the time of randomization
- Negative serum pregnancy test at screening if female of childbearing potential.
- Women of childbearing potential participating in the study must use a medically acceptable form of contraception.
- Sexually active male must agree to use a medically accepted form of contraception during the study. If partner is using and acceptable form of contraception, this criteria is not applicable.
- Subject is capable of understanding and signing an informed consent form
- Subject is able and willing to self-inject study drug or have a designee who can do so
- Subject is able and willing to take oral medication 11. Subject is able to store injectable test article at 2° C to 8° C 12. Demonstrates a negative tuberculosis screening test determined by chest
- Exculsion Criteria:
- Subject has received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist
- Subject has received any of the following DMARDs: methotrexate, leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, azathioprine, D-penicillamine, cyclophosphamide within the 6 months of screening visit by the rheumatologist
- Subject has received any investigational drug within 3 months of screening visit by the rheumatologist
- Subject has received any biologic agent in the past
- Subject has received any live (attenuated) vaccines within 4 weeks of screening visit by the rheumatologist
- Subject has received intra-articular corticosteroid injection within 4 weeks of screening visit by the rheumatologist
- Subject has received bolus intramuscular/intravenous treatment with corticosteroids (\>20 mg prednisone or equivalent) within 4 weeks of screening visit by the rheumatologist
- Subject is taking \> 10 mg/day of prednisone or equivalent within 4 weeks of screening visit by the rheumatologist
- A history or active presence of any of the following items will prevent enrollment:
- Significant concurrent medical diseases including cancer or a history of cancer Renal disease (creatinine level \> 175 ?mol/L) History of drug abuse or psychiatric disease that would interfere with the subject's ability to comply with the requirements of this protocol.
- History of alcohol abuse that would interfere with the subject's ability to comply with the requirements of this protocol.
- History of known liver cirrhosis, fibrosis, or fatty liver History of any viral hepatitis within 1 year of screening
- Active presence of the following will also prevent enrollment Subject has a significant active infection or any underlying diseases that could predispose subjects to infections according to the investigators criteria Demonstrates liver function abnormality through clinical significant hepatic enzymes results ( twice the upper limits of normal).
- Subject has leucopoenia (white blood cells \< 3500 x 106/L) Subject has thrombocytopenia (platelets \< 125 x 109/L) Subject has a hemoglobin level of \< 85 g/L Subject is scheduled for elective major surgery within the first year of study participation Pregnant or lactating women. Positive TB by PPD and abnormal chest ray
- Subject has a history of confirmed blood dyscrasias12. Subject has any condition judged by the physician to cause this study to be detrimental to the subject.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00783536
Start Date
November 1 2008
End Date
June 1 2010
Last Update
May 9 2022
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