A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis (DOTAR)

Wyeth

Status and phase

Withdrawn

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Etanercept + Methotrexate

Drug: DMARDS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00783536

0881A1-102380

Details and patient eligibility

About

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 received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the study. Study subjects will be randomized into one of two treatments groups and receive either etanercept + methotrexate or standard non-biologic DMARD therapy.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.