Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

Phase 2 Completed 159 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2005-08
Primary completion: 2006-10-19
Completion: 2006-10-19

Outcome

Missed primary endpoint

paper No statistically significant difference for the ACR20 was found between the ERB-041 treatment and placebo groups (P = 0.518). PMID 20556817 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PRINABEREL	Small molecule	5 mg	Oral
Subject	PRINABEREL	Small molecule	25 mg	Oral
Subject	PRINABEREL	Small molecule	75 mg	Oral
Background	Methotrexate	Small molecule	—	—