Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LX3305.201, LX2931 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | A low dose of LX3305; daily oral intake for 12 weeks |
|
| Mid Dose | Experimental | A mid dose of LX3305; daily oral intake for 12 weeks |
|
| High Dose | Experimental | A high dose of LX3305; daily oral intake for 12 weeks |
|
| Placebo | Placebo Comparator | Matching placebo dosing with daily oral intake for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX3305 low dose | Drug | A low dose of LX3305; daily oral intake for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 Response at Week 12 | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel P. Freiman, MD, MPH | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Gainesville | Florida | 32607 | United States | ||
| Lexicon Investigational Site |
There was a 4 week screening period prior to the 12-week treatment period.
There were 43 study centers in 6 countries (10 in the US, 8 in Bulgaria, 4 in Czech Republic, 7 in Hungary, 11 in Poland, and 3 in Serbia). The first subject was enrolled on 31 August 2009, and the last subject completed the study on 30 September 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | A low dose of LX3305; daily oral intake for 12 weeks |
| FG001 | Mid Dose | A mid dose of LX3305; daily oral intake for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LX3305 mid dose |
| Drug |
A mid dose of LX3305; daily oral intake for 12 weeks |
|
| LX3305 high dose | Drug | A high dose of LX3305; daily oral intake for 12 weeks |
|
| Placebo | Drug | Matching placebo dosing with daily oral intake for 12 weeks |
|
| Baseline and 12 weeks |
| ACR70 Response at Week 12 | 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). | Baseline and 12 weeks |
| Hybrid ACR Response at Week 12 | 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. | Baseline and 12 weeks |
| Change From Baseline in C-reactive Protein (mg/L) at Week 12 | The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12. | Baseline and 12 weeks |
| Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12 | The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12. | Baseline and 12 weeks |
| 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 |
| FG002 | High Dose | A high dose of LX3305; daily oral intake for 12 weeks |
| FG003 | Placebo | Matching placebo dosing with daily oral intake for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | A low dose of LX3305; daily oral intake for 12 weeks |
| BG001 | Mid Dose | A mid dose of LX3305; daily oral intake for 12 weeks |
| BG002 | High Dose | A high dose of LX3305; daily oral intake for 12 weeks |
| BG003 | Placebo | Matching placebo dosing with daily oral intake for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent to Treat Population | Posted | Number | Participants | Baseline and 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | ACR50 Response at Week 12 | 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). | Intent to Treat Population | Posted | Number | Participants | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | ACR70 Response at Week 12 | 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). | Intent to Treat Population | Posted | Number | Participants | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Hybrid ACR Response at Week 12 | 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. | Intent to Treat Population | Posted | Mean | Standard Deviation | Percent change | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in C-reactive Protein (mg/L) at Week 12 | The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12. | Intent to Treat Population | Posted | Mean | Standard Deviation | mg/L | Baseline and 12 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12 | The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12. | Intent to Treat Population | Posted | Mean | Standard Deviation | mm | Baseline and 12 weeks |
|
|
Adverse events were followed during the 12-week Treatment period and during the 30-day Follow-up period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | A low dose of LX3305; daily oral intake for 12 weeks | 2 | 55 | 10 | 55 | ||
| EG001 | Mid Dose | A mid dose of LX3305; daily oral intake for 12 weeks | 0 | 54 | 5 | 54 | ||
| EG002 | High Dose | A high dose of LX3305; daily oral intake for 12 weeks | 0 | 50 | 10 | 50 | ||
| EG003 | Placebo | Matching placebo dosing with daily oral intake for 12 weeks | 0 | 49 | 12 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
The sponsor requires that written permission be given before the PI can release any data publicly.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Freiman, MD, MPH | Lexicon Pharmaceuticals, Inc. | 281-863-3070 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Participants |
|
|