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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00783536
First received: October 29, 2008
Last updated: June 1, 2009
Last verified: June 2009

October 29, 2008
June 1, 2009
November 2008
June 2010   (final data collection date for primary outcome measure)
Low disease activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00783536 on ClinicalTrials.gov Archive Site
Effect of the combination therapy on physical function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis
An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Etanercept + Methotrexate
  • Drug: DMARDS
  • Experimental: 1
    • Clinical and demographic information
    • Clinical and Laboratory information
    Intervention: Drug: Etanercept + Methotrexate
  • Active Comparator: 2
    • Clinical and demographic information
    • Clinical and Laboratory information
    Intervention: Drug: DMARDS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
402
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subject age 18 years or older
  2. Diagnosis of RA
  3. Disease duration of ≥ 6 months and ≤ 2 years
  4. Active disease at the time of randomization
  5. Negative serum pregnancy test at screening if female of childbearing potential.
  6. Women of childbearing potential participating in the study must use a medically acceptable form of contraception.
  7. 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.
  8. Subject is capable of understanding and signing an informed consent form
  9. Subject is able and willing to self-inject study drug or have a designee who can do so
  10. 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:

  1. Subject has received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist
  2. 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
  3. Subject has received any investigational drug within 3 months of screening visit by the rheumatologist
  4. Subject has received any biologic agent in the past
  5. Subject has received any live (attenuated) vaccines within 4 weeks of screening visit by the rheumatologist
  6. Subject has received intra-articular corticosteroid injection within 4 weeks of screening visit by the rheumatologist
  7. Subject has received bolus intramuscular/intravenous treatment with corticosteroids (>20 mg prednisone or equivalent) within 4 weeks of screening visit by the rheumatologist
  8. Subject is taking > 10 mg/day of prednisone or equivalent within 4 weeks of screening visit by the rheumatologist
  9. 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

  10. 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

  11. 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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00783536
0881A1-102380
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP