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| ID | Type | Description | Link |
|---|---|---|---|
| B2381010 | Other Identifier | Pfizer | |
| 2005-001319-23 | EudraCT Number |
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The primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (MTX).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate plus ERB-041 for 12 weeks | Drug | |||
| Placebo for 12 weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| -ACR 20 response at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy measures include ACR 50 and ACR 70 response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For South Africa, please contact ZAFinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Largo | Florida | 33773 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20556817 | Derived | Roman-Blas JA, Castaneda S, Cutolo M, Herrero-Beaumont G. Efficacy and safety of a selective estrogen receptor beta agonist, ERB-041, in patients with rheumatoid arthritis: a 12-week, randomized, placebo-controlled, phase II study. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1588-93. doi: 10.1002/acr.20275. Epub 2010 Jun 15. |
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| Palm Harbor |
| Florida |
| 34684 |
| United States |
| Sarasota | Florida | 34239 | United States |
| Boise | Idaho | 83702 | United States |
| Kansas City | Kansas | 66160 | United States |
| Frederick | Maryland | 21702 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Duncansville | Pennsylvania | 16635-0909 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75231 | United States |
| San Antonio | Texas | 78217 | United States |
| Spokane | Washington | 99204 | United States |
| La Crosse | Wisconsin | 54601 | United States |
| Penticton | British Columbia | V2A 3G8 | Canada |
| Newmarket | Ontario | L3Y 3R7 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Montreal | Quebec | H2L 1S6 | Canada |
| Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Québec | G1W 4R4 | Canada |
| Békéscsaba | 5600 | Hungary |
| Budapest | 1027 | Hungary |
| Veszprém | 8200 | Hungary |
| Brescia | 25100 | Italy |
| Genova | 16132 | Italy |
| Pavia | 27100 | Italy |
| Roma | 00100 | Italy |
| Siena | 53100 | Italy |
| Jalisco | Guadalajara | 44620 | Mexico |
| Delegacion Cuahutemoc | 06700 | Mexico |
| Andalucia | Andalusia | 41013 | Spain |
| Castilla La Mancha | 19002 | Spain |
| Comunidad Valenciana | 46017 | Spain |
| Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| C478102 | ERB 041 |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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