Clinical trial NCT00141830: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: -ACR 20 response at Week 12
Secondary outcomes:
measure: Secondary efficacy measures include ACR 50 and ACR 70 response.
Other outcomes:
Locations:
city: Largo
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Kansas City
country: United States
state: Kansas
city: Frederick
country: United States
state: Maryland
city: Albuquerque
country: United States
state: New Mexico
city: Charlotte
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
city: Penticton
country: Canada
state: British Columbia
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montréal
country: Canada
state: Quebec
city: Trois-Rivières
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Budapest
country: Hungary
city: Békéscsaba
country: Hungary
city: Veszprém
country: Hungary
city: Brescia
country: Italy
city: Genova
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Jalisco
country: Mexico
state: Guadalajara
city: Delegacion Cuahutemoc
country: Mexico
city: Andalucia
country: Spain
city: Castilla La Mancha
country: Spain
city: Comunidad Valenciana
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For South Africa, please contact ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
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.