Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
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ClinicalTrials.gov Identifier: NCT00903383 |
Recruitment Status :
Completed
First Posted : May 18, 2009
Results First Posted : December 15, 2011
Last Update Posted : December 15, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: LX3305 low dose Drug: LX3305 mid dose Drug: LX3305 high dose Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 208 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Dose
A low dose of LX3305; daily oral intake for 12 weeks
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Drug: LX3305 low dose
A low dose of LX3305; daily oral intake for 12 weeks |
Experimental: Mid Dose
A mid dose of LX3305; daily oral intake for 12 weeks
|
Drug: LX3305 mid dose
A mid dose of LX3305; daily oral intake for 12 weeks |
Experimental: High Dose
A high dose of LX3305; daily oral intake for 12 weeks
|
Drug: LX3305 high dose
A high dose of LX3305; daily oral intake for 12 weeks |
Placebo Comparator: Placebo
Matching placebo dosing with daily oral intake for 12 weeks
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Drug: Placebo
Matching placebo dosing with daily oral intake for 12 weeks |
- ACR20 Response at Week 12 [ Time Frame: Baseline and 12 weeks ]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).
- ACR50 Response at Week 12 [ Time Frame: Baseline and 12 weeks ]Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 50% response criteria (ACR50) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR50, there had to be ≥50% improvement in swollen joint count, ≥50% improvement in painful/tender joint count, and ≥50% 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).
- ACR70 Response at Week 12 [ Time Frame: Baseline and 12 weeks ]Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 70% response criteria (ACR70) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR70, there had to be ≥70% improvement in swollen joint count, ≥70% improvement in painful/tender joint count, and ≥70% 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).
- Hybrid ACR Response at Week 12 [ Time Frame: Baseline and 12 weeks ]Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. The percentage improvement from baseline was computed in each of the components of the ACR. The average percent improvement was calculated and used with the subject's ACR20, ACR50, and ACR70 status to compute the hybrid ACR response, with a positive change indicating improvement.
- Change From Baseline in C-reactive Protein (mg/L) at Week 12 [ Time Frame: Baseline and 12 weeks ]The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.
- Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12 [ Time Frame: Baseline and 12 weeks ]The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903383
United States, Florida | |
Lexicon Investigational Site | |
Gainesville, Florida, United States, 32607 | |
Lexicon Investigational Site | |
Orange Park, Florida, United States, 32073 | |
Lexicon Investigational Site | |
Orlando, Florida, United States, 32804 | |
Lexicon Investigational Site | |
Tampa, Florida, United States, 33614 | |
United States, Maryland | |
Lexicon Investigational Site | |
Cumberland, Maryland, United States, 21502 | |
Lexicon Investigational Site | |
Hagerstown, Maryland, United States, 21740 | |
United States, Michigan | |
Lexicon Investigational Site | |
Kalamazoo, Michigan, United States, 49009 | |
United States, Mississippi | |
Lexicon Investigational Site | |
Flowood, Mississippi, United States, 39232 | |
United States, North Carolina | |
Lexicon Investigational Site | |
Hickory, North Carolina, United States, 28601 | |
United States, Pennsylvania | |
Lexicon Investigational Site | |
Philadelphia, Pennsylvania, United States, 19152 | |
United States, Tennessee | |
Lexicon Investigational Site | |
Nashville, Tennessee, United States, 37205 | |
United States, Texas | |
Lexicon Investigational Site | |
Dallas, Texas, United States, 75235 | |
United States, Wisconsin | |
Lexicon Investigational Site | |
La Crosse, Wisconsin, United States, 54601 | |
Bulgaria | |
Lexicon Investigational Site | |
Pleven, Bulgaria | |
Lexicon Investigational Site | |
Plovdiv, Bulgaria | |
Lexicon Investigational Site | |
Ruse, Bulgaria | |
Lexicon Investigational Site | |
Sofia, Bulgaria | |
Lexicon Investigational Site | |
Veliko Tarnovo, Bulgaria | |
Czech Republic | |
Lexicon Investigational Site | |
Bruntal, Czech Republic | |
Lexicon Investigational Site | |
Hlucin, Czech Republic | |
Lexicon Investigational Site | |
Sokolov, Czech Republic | |
Lexicon Investigational Site | |
Zlin, Czech Republic | |
Hungary | |
Lexicon Investigational Site | |
Bekescsaba, Hungary | |
Lexicon Investigational Site | |
Budapest, Hungary | |
Lexicon Investigational Site | |
Kecskemet, Hungary | |
Lexicon Investigational Site | |
Mako, Hungary | |
Lexicon Investigational Site | |
Sopron, Hungary | |
Lexicon Investigational Site | |
Veszprem, Hungary | |
Poland | |
Lexicon Investigational Site | |
Bialystok, Poland | |
Lexicon Investigational Site | |
Dzialdowo, Poland | |
Lexicon Investigational Site | |
Gdynia, Poland | |
Lexicon Investigational Site | |
Katowice, Poland | |
Lexicon Investigational Site | |
Lublin, Poland | |
Lexicon Investigational Site | |
Warszawa, Poland | |
Lexicon Investigational Site | |
Wloszczowa, Poland | |
Lexicon Investigational Site | |
Wroclaw, Poland | |
Serbia | |
Lexicon Investigational Site | |
Belgrade, Serbia | |
Lexicon Investigational Site | |
Niska Banja, Serbia |
Study Director: | Joel P. Freiman, MD, MPH | Lexicon Pharmaceuticals, Inc. |
Responsible Party: | Lexicon Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00903383 |
Other Study ID Numbers: |
Protocol LX3305.1-201-RA LX3305.201, LX2931 |
First Posted: | May 18, 2009 Key Record Dates |
Results First Posted: | December 15, 2011 |
Last Update Posted: | December 15, 2011 |
Last Verified: | November 2011 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |