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

• ClinicalTrials.gov Identifier: NCT00783536
• Recruitment Status: Withdrawn
• First Posted: October 31, 2008
• Last Update Posted: June 2, 2009
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: October 29, 2008
• First Posted Date: October 31, 2008
• Last Update Posted Date: June 2, 2009
• Study Start Date: November 2008
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 30, 2008): Low disease activity [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 30, 2008): Effect of the combination therapy on physical function [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis
• Official Title: 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
• 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis

Intervention

• Drug: Etanercept + Methotrexate
• Drug: DMARDS

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Estimated Enrollment (submitted: October 30, 2008): 402
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2010
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00783536
• Other Study ID Numbers: 0881A1-102380
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: June 2009