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NCT00393471 Clinical Trial

Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

Active Rheumatoid Arthritis Clinical Trial

Official title:
A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00393471
Other study ID # 0881A1-308
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2000
Est. completion date October 2001

Study information
Verified date October 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.

Description:

Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.

Recruitment information / eligibility
Status Completed
Enrollment 615
Est. completion date October 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion: - Generally healthy of at least 18 years of age with active rheumatoid arthritis. Exclusion: - A history or presence of clinically important medical disease.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Etanercept

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
See also
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Completed NCT03172325 - Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA Phase 3
Completed NCT00420199 - A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Phase 3
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Completed NCT01008852 - Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis Phase 2