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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00903383
Other study ID # Protocol LX3305.1-201-RA
Secondary ID LX3305.201, LX29
Status Completed
Phase Phase 2
First received May 14, 2009
Last updated November 11, 2011
Start date July 2009

Study information

Verified date November 2011
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
LX3305 low dose
A low dose of LX3305; daily oral intake for 12 weeks
LX3305 mid dose
A mid dose of LX3305; daily oral intake for 12 weeks
LX3305 high dose
A high dose of LX3305; daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks

Locations

Country Name City State
Bulgaria Lexicon Investigational Site Pleven
Bulgaria Lexicon Investigational Site Plovdiv
Bulgaria Lexicon Investigational Site Ruse
Bulgaria Lexicon Investigational Site Sofia
Bulgaria Lexicon Investigational Site Veliko Tarnovo
Czech Republic Lexicon Investigational Site Bruntal
Czech Republic Lexicon Investigational Site Hlucin
Czech Republic Lexicon Investigational Site Sokolov
Czech Republic Lexicon Investigational Site Zlin
Hungary Lexicon Investigational Site 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
Poland Lexicon Investigational Site 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
Serbia Lexicon Investigational Site Belgrade
Serbia Lexicon Investigational Site Niska Banja
United States Lexicon Investigational Site Cumberland Maryland
United States Lexicon Investigational Site Dallas Texas
United States Lexicon Investigational Site Flowood Mississippi
United States Lexicon Investigational Site Gainesville Florida
United States Lexicon Investigational Site Hagerstown Maryland
United States Lexicon Investigational Site Hickory North Carolina
United States Lexicon Investigational Site Kalamazoo Michigan
United States Lexicon Investigational Site La Crosse Wisconsin
United States Lexicon Investigational Site Nashville Tennessee
United States Lexicon Investigational Site Orange Park Florida
United States Lexicon Investigational Site Orlando Florida
United States Lexicon Investigational Site Philadelphia Pennsylvania
United States Lexicon Investigational Site Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Lexicon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Hungary,  Poland,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline and 12 weeks No
Secondary 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). Baseline and 12 weeks No
Secondary 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). Baseline and 12 weeks No
Secondary 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. Baseline and 12 weeks No
Secondary 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. Baseline and 12 weeks No
Secondary 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. Baseline and 12 weeks No
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