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

November 11, 2011 updated by: Lexicon Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Lexicon Investigational Site
      • Plovdiv, Bulgaria
        • Lexicon Investigational Site
      • Ruse, Bulgaria
        • Lexicon Investigational Site
      • Sofia, Bulgaria
        • Lexicon Investigational Site
      • Veliko Tarnovo, Bulgaria
        • Lexicon Investigational Site
  • Czech Republic
      • Bruntal, Czech Republic
        • Lexicon Investigational Site
      • Hlucin, Czech Republic
        • Lexicon Investigational Site
      • Sokolov, Czech Republic
        • Lexicon Investigational Site
      • Zlin, Czech Republic
        • Lexicon Investigational Site
  • Hungary
      • 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
        • Lexicon Investigational Site
  • Poland
      • 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
        • Lexicon Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Lexicon Investigational Site
      • Niska Banja, Serbia
        • Lexicon Investigational Site
  • United States
    • Florida
      • 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
        • Lexicon Investigational Site
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Lexicon Investigational Site
      • Hagerstown, Maryland, United States, 21740
        • Lexicon Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Lexicon Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Lexicon Investigational Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Lexicon Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19152
        • Lexicon Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Lexicon Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Lexicon Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Lexicon Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose
A low dose of LX3305; daily oral intake for 12 weeks
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
Drug: Placebo
Matching placebo dosing with daily oral intake for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 12 weeks
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).
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lexicon Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joel P. Freiman, MD, MPH, Lexicon Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol LX3305.1-201-RA
  • LX3305.201, LX2931

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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