Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion:
- Generally healthy of at least 18 years of age with active rheumatoid arthritis.
Exclusion:
- A history or presence of clinically important medical disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Australia, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For Czech Republic, WPPGCLI@wyeth.com | Principal Investigator |
| Trial Manager | For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.com | Principal Investigator |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager | For Germany, medinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Greece, decresg@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Leonards | New South Wales | 2065 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27175292 | Derived | 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. | |
| 18050208 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Trial Manager |
| For Italy, descresg@wyeth.com |
| Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Trial Manager | For Romania, WVPIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Spain, infomed@wyeth.com | Principal Investigator |
| Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com | Principal Investigator |
| Adelaide |
| 5000 |
| Australia |
| Southport | 4215 | Australia |
| Vienna | 1110 | Austria |
| Brussels | 5390 | Belgium |
| Diepenbeek | 3590 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Česká Lípa | 470 01 | Czechia |
| Prague | 128 500 | Czechia |
| Terezín | 411 55 | Czechia |
| Zlín | 760 01 | Czechia |
| Copenhagen | 2400 | Denmark |
| Herlev | 2370 | Denmark |
| Kuopio | 70100 | Finland |
| Rauma | 26100 | Finland |
| Tampere | 3311 | Finland |
| Vantaa | 01400 | Finland |
| Bordeaux | 33076 | France |
| Brest | 29609 | France |
| Créteil | 94010 | France |
| Grenoble | 38043 | France |
| Le Kremlin-Bicêtre | 94270 | France |
| Montpellier | 34295 | France |
| Nice | 06202 | France |
| Paris | 75013 | France |
| Paris | 75018 | France |
| Paris | 75475 | France |
| Rouen | 76031 | France |
| Strasbourg | 67098 | France |
| Toulouse | 31403 | France |
| Berlin | 10117 | Germany |
| Cologne | 50931 | Germany |
| Erlangen | 91054 | Germany |
| Herne | 44652 | Germany |
| Leipzig | 04103 | Germany |
| München | 80336 | Germany |
| Plauen | 08525 | Germany |
| Vogelsang | 39245 | Germany |
| Würzburg | 97070 | Germany |
| Athens | 11525 | Greece |
| Thessaloniki | 55134 | Greece |
| Jerusalem | 91120 | Israel |
| Petah Tikva | 49100 | Israel |
| Ferrara | 44100 | Italy |
| Florence | 50413 | Italy |
| Genova | 16132 | Italy |
| Milan | 20122 | Italy |
| Milan | 20162 | Italy |
| Naples | 80100 | Italy |
| Pavia | 27100 | Italy |
| Udine | 33100 | Italy |
| Alkmaar | 1815 | Netherlands |
| Arnhem | 6815 | Netherlands |
| Doetinchem | 7009 | Netherlands |
| Enschede | 7513 | Netherlands |
| Leeuwarden | 8934 | Netherlands |
| Maastricht | 6229 | Netherlands |
| Nijmegen | 6522 | Netherlands |
| Tilburg | 5042 | Netherlands |
| Venlo | 5912 | Netherlands |
| Drammen | 3004 | Norway |
| Oslo | 0319 | Norway |
| Elblag | 82-300 | Poland |
| Kalisz | 62-800 | Poland |
| Krakow | 30-119 | Poland |
| Warsaw | 02-637 | Poland |
| Wroclaw | 53-137 | Poland |
| Lisbon | 1000-247 | Portugal |
| Lisbon | 1349-019 | Portugal |
| Bucharest | 70231 | Romania |
| Cluj-Japoca | 3400 | Romania |
| Barcelona | 08036 | Spain |
| Guadalajara | 19002 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28046 | Spain |
| Santander | 39008 | Spain |
| Santiago de Compostela | 15706 | Spain |
| Jönköping | 55185 | Sweden |
| Kalmar | 39185 | Sweden |
| Linköping | 58185 | Sweden |
| Stockholm | 17176 | Sweden |
| Uppsala | 75185 | Sweden |
| London | E11 1NR | United Kingdom |
| North Yorks | HG2 7SX | United Kingdom |
| Trent | ST6 7AG | United Kingdom |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided