Clinical trial NCT00393471: Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Active Rheumatoid Arthritis
Keywords: Arthritis
Rheumatoid
Safety
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-27
Enrollment: 615
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion:

- Generally healthy of at least 18 years of age with active rheumatoid arthritis.

Exclusion:

- A history or presence of clinically important medical disease.

Primary outcomes:
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: St. Leonards
country: Australia
state: New South Wales
city: Adelaide
country: Australia
city: Southport
country: Australia
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Diepenbeek
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Ceska Lipa
country: Czechia
city: Praha
country: Czechia
city: Terezin
country: Czechia
city: Zlin
country: Czechia
city: Copenhagen
country: Denmark
city: Herlev
country: Denmark
city: Kuopio
country: Finland
city: Rauma
country: Finland
city: Tampere
country: Finland
city: Vantaa
country: Finland
city: Bordeaux
country: France
city: Brest Cedex
country: France
city: Creteil
country: France
city: Grenoble Cedex
country: France
city: Le Kremlin Bicetre
country: France
city: Montpellier Cedex
country: France
city: Nice Cedex
country: France
city: Paris Cedex
country: France
city: Paris
country: France
city: Paris
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Toulouse Cedex
country: France
city: Berlin
country: Germany
city: Erlangen
country: Germany
city: Herne
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Munchen
country: Germany
city: Plauen
country: Germany
city: Vogelsang
country: Germany
city: Wurzburg
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Jerusalem
country: Israel
city: Petah-Tikva
country: Israel
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Pavia
country: Italy
city: Udine
country: Italy
city: Alkmaar
country: Netherlands
city: Arnhem
country: Netherlands
city: Doetinchem
country: Netherlands
city: Enschede
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Tilburg
country: Netherlands
city: Venlo
country: Netherlands
city: Drammen
country: Norway
city: Oslo
country: Norway
city: Elblag
country: Poland
city: Kalisz
country: Poland
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Lisbon
country: Portugal
city: Lisbon
country: Portugal
city: Bucuresti
country: Romania
city: Cluj-Japoca
country: Romania
city: Barcelona
country: Spain
city: Guadalajara
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Santiago de Compostela
country: Spain
city: Jonkoping
country: Sweden
city: Kalmar
country: Sweden
city: Linkoping
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: London
country: United Kingdom
city: North Yorkshire
country: United Kingdom
city: Trent
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Czech Republic, WPPGCLI@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK/Great Britian, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016 Apr 21;2(1):e000186. doi: 10.1136/rmdopen-2015-000186. eCollection 2016.
citation: van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R, Pedersen R, MacPeek D, Wajdula J, Fatenejad S. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Dec;56(12):3928-39. doi: 10.1002/art.23141.