Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

NCT01578850

Last updated date
Study Location
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
Salvador, Bahia, 40050-410, Brazil
Contact
1-800-718-1021

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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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.

2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Subjects who used any of the following systemic treatments during the washout periods
given below:


1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in
dose within 28 days of baseline.


2. Treatment with more than 1 NSAID within 14 days at baseline.


3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate
within 28 days of baseline.


4. Subjects will be allowed to continue the following non biologic DMARDs:
sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs
(including but not limited to gold, penicillamine, azathioprine,
cyclophospamide), and biologic DMARDs must have been discontinued at least 2
months prior to Week 1.


5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.


2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.


3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
Official Title  ICMJE A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)
Brief Summary To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etanercept
    etanercept 50mg once weekly + methotrexate with or without other DMARDs
  • Drug: placebo
    etanercept placebo once weekly + methotrexate with or without other DMARDs
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Drug: Etanercept
  • Placebo Comparator: Group B
    Intervention: Drug: placebo
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2015)
491
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2012)
320
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
  2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ?10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria:

  1. Subjects who used any of the following systemic treatments during the washout periods given below:

    1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
    2. Treatment with more than 1 NSAID within 14 days at baseline.
    3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
    4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
    5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
  2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
  3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 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 Brazil,   China,   Colombia,   Czech Republic,   Egypt,   Hungary,   Jordan,   Lebanon,   Malaysia,   Mexico,   Philippines,   Qatar,   Romania,   Russian Federation,   South Africa,   Taiwan,   Thailand,   Ukraine,   United Arab Emirates
Removed Location Countries Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT01578850
Other Study ID Numbers  ICMJE B1801315
2011-005448-87 ( EudraCT Number )
B1801315 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2016

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