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Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate

NCT00903383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2011-12-15

Study results available
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Summary

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.

Conditions

Interventions

DRUG

LX3305 low dose

A low dose of LX3305; daily oral intake for 12 weeks

DRUG

LX3305 mid dose

A mid dose of LX3305; daily oral intake for 12 weeks

DRUG

LX3305 high dose

A high dose of LX3305; daily oral intake for 12 weeks

DRUG

Placebo

Matching placebo dosing with daily oral intake for 12 weeks

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joel P. Freiman, MD, MPH · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-09-30

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903383 on ClinicalTrials.gov