Skip to main content
OpenTrials
Completed

NCT Number: NCT00903383

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lexicon Investigational Site, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LX3305 low dose

Drug

A low dose of LX3305; daily oral intake for 12 weeks

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
First posted
May 18, 2009
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.