Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
NCT ID: NCT00903383
Last Updated: 2011-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose
A low dose of LX3305; daily oral intake for 12 weeks
LX3305 low dose
A low dose of LX3305; daily oral intake for 12 weeks
Mid Dose
A mid dose of LX3305; daily oral intake for 12 weeks
LX3305 mid dose
A mid dose of LX3305; daily oral intake for 12 weeks
High Dose
A high dose of LX3305; daily oral intake for 12 weeks
LX3305 high dose
A high dose of LX3305; daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Interventions
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LX3305 low dose
A low dose of LX3305; daily oral intake for 12 weeks
LX3305 mid dose
A mid dose of LX3305; daily oral intake for 12 weeks
LX3305 high dose
A high dose of LX3305; daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Joel P. Freiman, MD, MPH
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Gainesville, Florida, United States
Lexicon Investigational Site
Orange Park, Florida, United States
Lexicon Investigational Site
Orlando, Florida, United States
Lexicon Investigational Site
Tampa, Florida, United States
Lexicon Investigational Site
Cumberland, Maryland, United States
Lexicon Investigational Site
Hagerstown, Maryland, United States
Lexicon Investigational Site
Kalamazoo, Michigan, United States
Lexicon Investigational Site
Flowood, Mississippi, United States
Lexicon Investigational Site
Hickory, North Carolina, United States
Lexicon Investigational Site
Philadelphia, Pennsylvania, United States
Lexicon Investigational Site
Nashville, Tennessee, United States
Lexicon Investigational Site
Dallas, Texas, United States
Lexicon Investigational Site
La Crosse, Wisconsin, 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
Countries
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Other Identifiers
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LX3305.201, LX2931
Identifier Type: -
Identifier Source: secondary_id
Protocol LX3305.1-201-RA
Identifier Type: -
Identifier Source: org_study_id