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Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Campsie, New South Wales, 2194 Australia
Contact
1-800-718-1021
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

- Diagnosis of rheumatoid arthritis.

- Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but
no more than 25 mg/week) for the treatment of rheumatoid arthritis.

- Active rheumatoid arthritis at the time of screening.

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

- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
inhibitors, or other biologic agents.

- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other
than MTX within 28 days before baseline.

- Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at
baseline.

NCT00565409
Pfizer
Completed
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

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Similar Trials

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: Etanercept
    Subcutaneous (SC), 50 mg, once weekly for 88 weeks
    Other Name: Enbrel
  • Drug: Methotrexate

    Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

    If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

  • Drug: Etanercept
    Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
  • Drug: Placebo
    Subcutaneous (SC), once weekly from week 36 to week 88.
  • Active Comparator: 1
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Active Comparator: 2
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Placebo Comparator: 3
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
834
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis.
  • Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
  • Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
  • Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
  • Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Chile,   Colombia,   Czech Republic,   Former Serbia and Montenegro,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
Brazil,   Korea, Democratic People's Republic of,   Serbia
 
NCT00565409
0881A1-4423
B1801003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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