Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

NCT ID: NCT00141830

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-10-19

Brief Summary

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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).

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Methotrexate plus ERB-041 for 12 weeks

Intervention Type DRUG

Placebo for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For South Africa, please contact [email protected]

Locations

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Largo, Florida, United States

Site Status

Palm Harbor, Florida, United States

Site Status

Sarasota, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

Kansas City, Kansas, United States

Site Status

Frederick, Maryland, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Spokane, Washington, United States

Site Status

La Crosse, Wisconsin, United States

Site Status

Penticton, British Columbia, Canada

Site Status

Newmarket, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Trois-Rivières, Quebec, Canada

Site Status

Saskatoon, Saskatchewan, Canada

Site Status

Québec, , Canada

Site Status

Békéscsaba, , Hungary

Site Status

Budapest, , Hungary

Site Status

Veszprém, , Hungary

Site Status

Brescia, , Italy

Site Status

Genova, , Italy

Site Status

Pavia, , Italy

Site Status

Roma, , Italy

Site Status

Siena, , Italy

Site Status

Jalisco, Guadalajara, Mexico

Site Status

Delegacion Cuahutemoc, , Mexico

Site Status

Andalucia, Andalusia, Spain

Site Status

Castilla La Mancha, , Spain

Site Status

Comunidad Valenciana, , Spain

Site Status

Madrid, , Spain

Site Status

Countries

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United States Canada Hungary Italy Mexico Spain

References

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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.

Reference Type DERIVED
PMID: 20556817 (View on PubMed)

Other Identifiers

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B2381010

Identifier Type: OTHER

Identifier Source: secondary_id

2005-001319-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3142A1-202

Identifier Type: -

Identifier Source: org_study_id

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