NCT00105976

Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)

A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (planned)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the mother and the fetus are much higher than normal. It has been observed that women with RA (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third trimester. At this time, the levels of AFP in the blood of the mother and fetus are the highest. This observation led researchers to begin examining AFP as a possible treatment for RA.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MM-093

Timeline

• Start date: 2005-02-01
• First posted: 2005-03-21
• Last updated: 2008-07-11

Locations

38 sites across 1 country: United States