Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
NCT ID: NCT00847886
Last Updated: 2010-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2009-02-28
2009-03-31
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
TRIPLE
Study Groups
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LX3305
Daily oral intake of LX3305 for 14 days.
LX3305
Daily oral intake of LX3305 for 14 days.
Methotrexate
Once weekly stable-dose methotrexate.
LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
Methotrexate
Once weekly stable-dose methotrexate.
Interventions
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LX3305
Daily oral intake of LX3305 for 14 days.
LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
Methotrexate
Once weekly stable-dose methotrexate.
Eligibility Criteria
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Inclusion Criteria
* Must be willing to practice 2 adequate methods of contraception for the duration of the study
* Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
* Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
* Ability to provide written informed consent
Exclusion Criteria
* History of other current inflammatory arthritis
* History of opportunistic infection
* History of recurrent infections or current infection 2 weeks prior to start of study
* Presence of significant, uncontrolled medical problems
* Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
* Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
* Receipt of live vaccine within 8 weeks prior to study start
* Rheumatoid arthritis, functional class IV as defined by ACR criteria
18 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Lexicon Pharmaceuticals, Inc.
Principal Investigators
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Philip M. Brown, MD, JD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Metroplex Clinical Research Center
Dallas, Texas, United States
Countries
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Other Identifiers
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LX3305.104
Identifier Type: -
Identifier Source: secondary_id
LX2931
Identifier Type: -
Identifier Source: secondary_id
Protocol LX3305.1-104-DDI
Identifier Type: -
Identifier Source: org_study_id
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