You are here

Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Ostrava, , 722 00 Czech Republic
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.

- Documented evidence, confirmed by a blinded 3rd party assessor, of at least one
erosion observed by X-ray at randomization based on X-ray taken at the screening
visit.

- Have received MTX as stable dose for 28 days prior to the screening visit.

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

- Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF)
-a inhibitors, anakinra or other biological agents.

- Receipt of any DMARD, other than MTX, within 28 days before screening.

NCT00706797
Pfizer
Terminated
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

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
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel? (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity
To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: etanercept (EnbrelTM)
  • Drug: methotrexate
  • Active Comparator: Usual care
    Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
    Intervention: Drug: methotrexate
  • Active Comparator: ETN + MTX
    Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
    Interventions:
    • Drug: etanercept (EnbrelTM)
    • Drug: methotrexate


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
141
May 2010
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
  • Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
  • Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

  • Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
  • Receipt of any DMARD, other than MTX, within 28 days before screening.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Spain,   Turkey,   United Kingdom
Austria,   Croatia,   United States
 
NCT00706797
0881X1-4437
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2011

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