You are here

Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Consultorios Especializados en Investigaciones Medicas
Capital Federal, Buenos Aires, C1425EKF Argentina
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
18-69 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of Rheumatoid Arthritis (RA)

- Currently receiving a suboptimal response to a stable dose of methotrexate for
treatment of Rheumatoid Arthritis (RA)

- Active Rheumatoid Arthritis (RA) at time of screening and baseline

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
inhibitors, or other biologic agents

- Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than
methotrexate, at screening

- Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate,
within 3 months before screening

NCT00848354
Pfizer
Completed
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Systemic Lupus Erythematosus, Rheumatoid Arthritis
NCT03334851
All Genders
18+
Years
Multiple Sites
Hip Osteoarthritis, Knee Osteoarthritis
NCT02709486
All Genders
18+
Years
Multiple Sites
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: Phase 1: Etanercept
    Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
    Other Name: Enbrel
  • Drug: Phase 1: Methotrexate
    Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
  • Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX

    Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.

    Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.

    Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.

    Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.

  • Drug: Phase 1: Methotrexate
    Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
  • Drug: Phase 1: Conventiaonal DMARD
    Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
  • Experimental: Phase 1 Etanercept + methotrexate
    Phase 1: Etanercept + methotrexate
    Interventions:
    • Biological: Phase 1: Etanercept
    • Drug: Phase 1: Methotrexate
    • Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX
  • Active Comparator: Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
    Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
    Interventions:
    • Drug: Phase 1: Methotrexate
    • Drug: Phase 1: Conventiaonal DMARD


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
429
April 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis (RA)
  • Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
  • Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
  • Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
  • Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Colombia,   Mexico,   Panama
Brazil,   Ecuador,   Spain,   Venezuela
 
NCT00848354
0881A1-4532
B1801004 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Amgen
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now