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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LX3305 low dose
LX3305 mid dose
LX3305 high dose
Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose

Mid Dose

High Dose

Placebo

Arm Description

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

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

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

Matching placebo dosing with daily oral intake for 12 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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.
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.

Full Information

First Posted
May 14, 2009
Last Updated
November 11, 2011
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00903383
Brief Title
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
A low dose of LX3305; daily oral intake for 12 weeks
Arm Title
Mid Dose
Arm Type
Experimental
Arm Description
A mid dose of LX3305; daily oral intake for 12 weeks
Arm Title
High Dose
Arm Type
Experimental
Arm Description
A high dose of LX3305; daily oral intake for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo dosing with daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
LX3305 low dose
Intervention Description
A low dose of LX3305; daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
LX3305 mid dose
Intervention Description
A mid dose of LX3305; daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
LX3305 high dose
Intervention Description
A high dose of LX3305; daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo dosing with daily oral intake for 12 weeks
Primary Outcome Measure Information:
Title
ACR20 Response at Week 12
Description
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).
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
ACR50 Response at Week 12
Description
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).
Time Frame
Baseline and 12 weeks
Title
ACR70 Response at Week 12
Description
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).
Time Frame
Baseline and 12 weeks
Title
Hybrid ACR Response at Week 12
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in C-reactive Protein (mg/L) at Week 12
Description
The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12
Description
The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel P. Freiman, MD, MPH
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Lexicon Investigational Site
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Lexicon Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Lexicon Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Lexicon Investigational Site
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Lexicon Investigational Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Lexicon Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Lexicon Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Lexicon Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Lexicon Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Lexicon Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Lexicon Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Lexicon Investigational Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Lexicon Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Ruse
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Bruntal
Country
Czech Republic
Facility Name
Lexicon Investigational Site
City
Hlucin
Country
Czech Republic
Facility Name
Lexicon Investigational Site
City
Sokolov
Country
Czech Republic
Facility Name
Lexicon Investigational Site
City
Zlin
Country
Czech Republic
Facility Name
Lexicon Investigational Site
City
Bekescsaba
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Budapest
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Kecskemet
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Mako
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Sopron
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Veszprem
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Bialystok
Country
Poland
Facility Name
Lexicon Investigational Site
City
Dzialdowo
Country
Poland
Facility Name
Lexicon Investigational Site
City
Gdynia
Country
Poland
Facility Name
Lexicon Investigational Site
City
Katowice
Country
Poland
Facility Name
Lexicon Investigational Site
City
Lublin
Country
Poland
Facility Name
Lexicon Investigational Site
City
Warszawa
Country
Poland
Facility Name
Lexicon Investigational Site
City
Wloszczowa
Country
Poland
Facility Name
Lexicon Investigational Site
City
Wroclaw
Country
Poland
Facility Name
Lexicon Investigational Site
City
Belgrade
Country
Serbia
Facility Name
Lexicon Investigational Site
City
Niska Banja
Country
Serbia

12. IPD Sharing Statement

Learn more about this trial

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

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