NCT01724931

Aminopterin Dose Finding Treatment for Methotrexate-Naïve Rheumatoid Arthritis

A Phase 2 Double-Blind, Placebo-Controlled, Randomized Dose Finding Study For The Efficacy And Safety Of Aminopterin In Methotrexate-Naive Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Syntrix Biosystems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether aminopterin is effective in the treatment of rheumatoid arthritis (RA).

Detailed description

This is a double-blind, randomized, placebo-controlled, dose ranging study that will evaluate the safety, efficacy, and pharmacokinetic properties (the absorption, distribution and excretion) of aminopterin following oral administration by subjects with active rheumatoid arthritis (≥ 6 tender and ≥ 6 swollen joints) who have not been treated with methotrexate (MTX). Subjects are randomized to one of three treatments: placebo, 1 mg of LD-aminopterin, or 3 mg of LD-aminopterin in a 1:1:1 ratio. The study hypothesis is that the 3 mg LD-aminopterin per week is effective at treating rheumatoid arthritis compared to placebo.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	LD-aminopterin
DRUG	placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2015-02-01
• First posted: 2012-11-12
• Last updated: 2015-05-20

Locations

15 sites across 1 country: Ukraine