Clinical trial NCT00903383: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: ACR20 Response at Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: ACR50 Response at Week 12
timeFrame: Baseline and 12 weeks
measure: ACR70 Response at Week 12
timeFrame: Baseline and 12 weeks
measure: Hybrid ACR Response at Week 12
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in C-reactive Protein (mg/L) at Week 12
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Orange Park
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Tampa
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Cumberland
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Kalamazoo
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Lexicon Investigational Site
state: Mississippi
city: Hickory
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Lexicon Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
city: La Crosse
country: United States
facility: Lexicon Investigational Site
state: Wisconsin
city: Pleven
country: Bulgaria
facility: Lexicon Investigational Site
city: Plovdiv
country: Bulgaria
facility: Lexicon Investigational Site
city: Ruse
country: Bulgaria
facility: Lexicon Investigational Site
city: Sofia
country: Bulgaria
facility: Lexicon Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Lexicon Investigational Site
city: Bruntal
country: Czech Republic
facility: Lexicon Investigational Site
city: Hlucin
country: Czech Republic
facility: Lexicon Investigational Site
city: Sokolov
country: Czech Republic
facility: Lexicon Investigational Site
city: Zlin
country: Czech Republic
facility: Lexicon Investigational Site
city: Bekescsaba
country: Hungary
facility: Lexicon Investigational Site
city: Budapest
country: Hungary
facility: Lexicon Investigational Site
city: Kecskemet
country: Hungary
facility: Lexicon Investigational Site
city: Mako
country: Hungary
facility: Lexicon Investigational Site
city: Sopron
country: Hungary
facility: Lexicon Investigational Site
city: Veszprem
country: Hungary
facility: Lexicon Investigational Site
city: Bialystok
country: Poland
facility: Lexicon Investigational Site
city: Dzialdowo
country: Poland
facility: Lexicon Investigational Site
city: Gdynia
country: Poland
facility: Lexicon Investigational Site
city: Katowice
country: Poland
facility: Lexicon Investigational Site
city: Lublin
country: Poland
facility: Lexicon Investigational Site
city: Warszawa
country: Poland
facility: Lexicon Investigational Site
city: Wloszczowa
country: Poland
facility: Lexicon Investigational Site
city: Wroclaw
country: Poland
facility: Lexicon Investigational Site
city: Belgrade
country: Serbia
facility: Lexicon Investigational Site
city: Niska Banja
country: Serbia
facility: Lexicon Investigational Site
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Joel P. Freiman, MD, MPH
role: STUDY_DIRECTOR
References: