Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy
2 other identifiers
interventional
208
6 countries
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedResults Posted
Study results publicly available
December 15, 2011
CompletedDecember 15, 2011
November 1, 2011
1.2 years
May 14, 2009
October 3, 2011
November 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
ACR20 Response at Week 12
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
Baseline and 12 weeks
Secondary Outcomes (5)
ACR50 Response at Week 12
Baseline and 12 weeks
ACR70 Response at Week 12
Baseline and 12 weeks
Hybrid ACR Response at Week 12
Baseline and 12 weeks
Change From Baseline in C-reactive Protein (mg/L) at Week 12
Baseline and 12 weeks
Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12
Baseline and 12 weeks
Study Arms (4)
Low Dose
EXPERIMENTALA low dose of LX3305; daily oral intake for 12 weeks
Mid Dose
EXPERIMENTALA mid dose of LX3305; daily oral intake for 12 weeks
High Dose
EXPERIMENTALA high dose of LX3305; daily oral intake for 12 weeks
Placebo
PLACEBO COMPARATORMatching placebo dosing with daily oral intake for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Males and females aged 18-75 years old
- Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
- Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level \> upper limit of normal
- Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
- Ability to provide written informed consent
You may not qualify if:
- RA diagnosis prior to 16 years of age (Juvenile RA)
- Lack of response to \>3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to \>1 biologic DMARD
- Use of DMARDs other than MTX within 12 weeks prior to Day 1
- Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
- Blood donation or receipt of live vaccine within 4 weeks prior to Day 1
- Major surgical procedure within 8 weeks prior to Day 1
- Any systemic inflammatory condition, recurrent infection, or current infection other than onychomycosis
- History of cancer within 5 years prior to Day 1
- Presence of hepatic or biliary disease
- History of tuberculosis
- History of human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Lexicon Investigational Site
Gainesville, Florida, 32607, United States
Lexicon Investigational Site
Orange Park, Florida, 32073, United States
Lexicon Investigational Site
Orlando, Florida, 32804, United States
Lexicon Investigational Site
Tampa, Florida, 33614, United States
Lexicon Investigational Site
Cumberland, Maryland, 21502, United States
Lexicon Investigational Site
Hagerstown, Maryland, 21740, United States
Lexicon Investigational Site
Kalamazoo, Michigan, 49009, United States
Lexicon Investigational Site
Flowood, Mississippi, 39232, United States
Lexicon Investigational Site
Hickory, North Carolina, 28601, United States
Lexicon Investigational Site
Philadelphia, Pennsylvania, 19152, United States
Lexicon Investigational Site
Nashville, Tennessee, 37205, United States
Lexicon Investigational Site
Dallas, Texas, 75235, United States
Lexicon Investigational Site
La Crosse, Wisconsin, 54601, United States
Lexicon Investigational Site
Pleven, Bulgaria
Lexicon Investigational Site
Plovdiv, Bulgaria
Lexicon Investigational Site
Rousse, Bulgaria
Lexicon Investigational Site
Sofia, Bulgaria
Lexicon Investigational Site
Veliko Tarnovo, Bulgaria
Lexicon Investigational Site
Bruntál, Czechia
Lexicon Investigational Site
Hlučín, Czechia
Lexicon Investigational Site
Sokolov, Czechia
Lexicon Investigational Site
Zlín, Czechia
Lexicon Investigational Site
Békéscsaba, Hungary
Lexicon Investigational Site
Budapest, Hungary
Lexicon Investigational Site
Kecskemét, Hungary
Lexicon Investigational Site
Makó, Hungary
Lexicon Investigational Site
Sopron, Hungary
Lexicon Investigational Site
Veszprém, Hungary
Lexicon Investigational Site
Bialystok, Poland
Lexicon Investigational Site
Działdowo, Poland
Lexicon Investigational Site
Gdynia, Poland
Lexicon Investigational Site
Katowice, Poland
Lexicon Investigational Site
Lublin, Poland
Lexicon Investigational Site
Warsaw, Poland
Lexicon Investigational Site
Wroclaw, Poland
Lexicon Investigational Site
Włoszczowa, Poland
Lexicon Investigational Site
Belgrade, Serbia
Lexicon Investigational Site
Niška Banja, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joel Freiman, MD, MPH
- Organization
- Lexicon Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Joel P. Freiman, MD, MPH
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
July 1, 2009
Primary Completion
September 1, 2010
Last Updated
December 15, 2011
Results First Posted
December 15, 2011
Record last verified: 2011-11