Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00141830
Collaborator
(none)
159
35
14.6
4.5
0.3
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy
Study Start Date
:
Aug 1, 2005
Actual Primary Completion Date
:
Oct 19, 2006
Actual Study Completion Date
:
Oct 19, 2006
Outcome Measures
Primary Outcome Measures
- -ACR 20 response at Week 12 []
Secondary Outcome Measures
- Secondary efficacy measures include ACR 50 and ACR 70 response. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a stable dose of methotrexate for at least 12 weeks
-
Rheumatoid arthritis onset after 16 years of age
Exclusion Criteria:
-
Any significant health problem other than rheumatoid arthritis
-
History of male or female reproductive system cancer
-
Clinically significant laboratory abnormalities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Largo | Florida | United States | 33773 | |
| 2 | Palm Harbor | Florida | United States | 34684 | |
| 3 | Sarasota | Florida | United States | 34239 | |
| 4 | Boise | Idaho | United States | 83702 | |
| 5 | Kansas City | Kansas | United States | 66160 | |
| 6 | Frederick | Maryland | United States | 21702 | |
| 7 | Albuquerque | New Mexico | United States | 87131 | |
| 8 | Charlotte | North Carolina | United States | 28210 | |
| 9 | Duncansville | Pennsylvania | United States | 16635-0909 | |
| 10 | Austin | Texas | United States | 78705 | |
| 11 | Dallas | Texas | United States | 75231 | |
| 12 | San Antonio | Texas | United States | 78217 | |
| 13 | Spokane | Washington | United States | 99204 | |
| 14 | La Crosse | Wisconsin | United States | 54601 | |
| 15 | Penticton | British Columbia | Canada | V2A 3G8 | |
| 16 | Newmarket | Ontario | Canada | L3Y 3R7 | |
| 17 | Toronto | Ontario | Canada | M5T 2S8 | |
| 18 | Montréal | Quebec | Canada | H2L 1S6 | |
| 19 | Trois-Rivières | Quebec | Canada | G8Z 1Y2 | |
| 20 | Saskatoon | Saskatchewan | Canada | S7K 0H6 | |
| 21 | Quebec | Canada | G1W 4R4 | ||
| 22 | Budapest | Hungary | 1027 | ||
| 23 | Békéscsaba | Hungary | 5600 | ||
| 24 | Veszprém | Hungary | 8200 | ||
| 25 | Brescia | Italy | 25100 | ||
| 26 | Genova | Italy | 16132 | ||
| 27 | Pavia | Italy | 27100 | ||
| 28 | Roma | Italy | 00100 | ||
| 29 | Siena | Italy | 53100 | ||
| 30 | Jalisco | Guadalajara | Mexico | 44620 | |
| 31 | Delegacion Cuahutemoc | Mexico | 06700 | ||
| 32 | Andalucia | Spain | 41013 | ||
| 33 | Castilla La Mancha | Spain | 19002 | ||
| 34 | Comunidad Valenciana | Spain | 46017 | ||
| 35 | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
- Principal Investigator: Trial Manager, For South Africa, please contact ZAFinfo@wyeth.com
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00141830
Other Study ID Numbers:
- 3142A1-202
- B2381010
- 2005-001319-23
First Posted:
Sep 1, 2005
Last Update Posted:
Sep 29, 2020
Last Verified:
Sep 1, 2020
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms: