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

May 14, 2009
November 11, 2011
July 2009
September 2010   (final data collection date for primary outcome measure)
ACR20 Response at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
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).
  • Safety and tolerability (physical examinations, monitoring of adverse events, clinical laboratory tests, vital signs measurements, and ECGs). [ Time Frame: Serially over the 12-week treatment period and at 2 weeks post-dose follow up ] [ Designated as safety issue: No ]
  • Efficacy (ACR20) [ Time Frame: Serially over the 12-week treatment period and at 2 weeks post-dose follow up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00903383 on ClinicalTrials.gov Archive Site
  • ACR50 Response at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.
ACR20, ACR50, ACR70, Hybrid ACR response measure, DAS28, and biomarkers of interest [ Time Frame: Serially over the 12-week treatment period and at 2 weeks post-dose follow up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: LX3305 low dose
    A low dose of LX3305; daily oral intake for 12 weeks
  • Drug: LX3305 mid dose
    A mid dose of LX3305; daily oral intake for 12 weeks
  • Drug: LX3305 high dose
    A high dose of LX3305; daily oral intake for 12 weeks
  • Drug: Placebo
    Matching placebo dosing with daily oral intake for 12 weeks
  • Experimental: Low Dose
    A low dose of LX3305; daily oral intake for 12 weeks
    Intervention: Drug: LX3305 low dose
  • Experimental: Mid Dose
    A mid dose of LX3305; daily oral intake for 12 weeks
    Intervention: Drug: LX3305 mid dose
  • Experimental: High Dose
    A high dose of LX3305; daily oral intake for 12 weeks
    Intervention: Drug: LX3305 high dose
  • Placebo Comparator: Placebo
    Matching placebo dosing with daily oral intake for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
Not Provided
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   Hungary,   Poland,   Serbia
 
NCT00903383
Protocol LX3305.1-201-RA, LX3305.201, LX2931
No
Lexicon Pharmaceuticals
Lexicon Pharmaceuticals
Not Provided
Study Director: Joel P. Freiman, MD, MPH Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP