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

NCT00783536

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etanercept + Methotrexate
  • Drug: DMARDS
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Estimated Enrollment  ICMJE
 (submitted: October 30, 2008)
402
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00783536
Other Study ID Numbers  ICMJE 0881A1-102380
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2009

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