Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141830

Enrollment

159

Registered

2005-09-01

Start date

2005-08-31

Completion date

2006-10-19

Last updated

2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

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).

Interventions

DRUGMethotrexate plus ERB-041 for 12 weeks

DRUGPlacebo for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
-ACR 20 response at Week 12	—

Secondary

Measure	Time frame
Secondary efficacy measures include ACR 50 and ACR 70 response.	—

Countries

Canada, Hungary, Italy, Mexico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026