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Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Methotrexate plus ERB-041 for 12 weeks
Placebo for 12 weeks
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

-ACR 20 response at Week 12

Secondary Outcome Measures

Secondary efficacy measures include ACR 50 and ACR 70 response.

Full Information

First Posted
August 30, 2005
Last Updated
September 25, 2020
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00141830
Brief Title
Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
October 19, 2006 (Actual)
Study Completion Date
October 19, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methotrexate plus ERB-041 for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo for 12 weeks
Primary Outcome Measure Information:
Title
-ACR 20 response at Week 12
Secondary Outcome Measure Information:
Title
Secondary efficacy measures include ACR 50 and ACR 70 response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For South Africa, please contact ZAFinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635-0909
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 3G8
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
City
Békéscsaba
ZIP/Postal Code
5600
Country
Hungary
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
City
Brescia
ZIP/Postal Code
25100
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Roma
ZIP/Postal Code
00100
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Jalisco
State/Province
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
City
Delegacion Cuahutemoc
ZIP/Postal Code
06700
Country
Mexico
City
Andalucia
ZIP/Postal Code
41013
Country
Spain
City
Castilla La Mancha
ZIP/Postal Code
19002
Country
Spain
City
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20556817
Citation
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.
Results Reference
derived

Learn more about this trial

Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

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