Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00903383
First received: May 14, 2009
Last updated: November 11, 2011
Last verified: November 2011
Results First Received: October 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: LX3305 low dose
Drug: LX3305 mid dose
Drug: LX3305 high dose
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a 4 week screening period prior to the 12-week treatment period.

Reporting Groups
  Description
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
High Dose A high dose of LX3305; daily oral intake for 12 weeks
Placebo Matching placebo dosing with daily oral intake for 12 weeks

Participant Flow:   Overall Study
    Low Dose     Mid Dose     High Dose     Placebo  
STARTED     55     54     50     49  
COMPLETED     48     48     47     44  
NOT COMPLETED     7     6     3     5  
Adverse Event                 1                 2                 3                 1  
Physician Decision                 1                 2                 0                 0  
Lost to Follow-up                 0                 0                 0                 1  
Decision of Sponsor                 1                 0                 0                 0  
Withdrawal by Subject                 4                 1                 0                 2  
Patient Decision - Lack of Efficacy                 0                 1                 0                 0  
Patient Decision                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
High Dose A high dose of LX3305; daily oral intake for 12 weeks
Placebo Matching placebo dosing with daily oral intake for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Low Dose     Mid Dose     High Dose     Placebo     Total  
Number of Participants  
[units: participants]
  55     54     50     49     208  
Age  
[units: years]
Mean ± Standard Deviation
  56.5  ± 9.25     55.8  ± 9.20     56.4  ± 10.89     57.5  ± 10.19     56.5  ± 9.83  
Gender  
[units: participants]
         
Female     47     43     37     41     168  
Male     8     11     13     8     40  



  Outcome Measures
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1.  Primary:   ACR20 Response at Week 12   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   ACR50 Response at Week 12   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   ACR70 Response at Week 12   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Hybrid ACR Response at Week 12   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Change From Baseline in C-reactive Protein (mg/L) at Week 12   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Joel Freiman, MD, MPH
Organization: Lexicon Pharmaceuticals, Inc.
phone: 281-863-3070


No publications provided


Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00903383     History of Changes
Other Study ID Numbers: Protocol LX3305.1-201-RA, LX3305.201, LX2931
Study First Received: May 14, 2009
Results First Received: October 3, 2011
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration