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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00903383
• Date of registration: 14/05/2009
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals
• Public title: Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00903383
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Joel P. Freiman, MD, MPH
• Affiliation: Lexicon Pharmaceuticals, Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: LX3305 high dose

Drug: LX3305 low dose

Drug: Placebo

Drug: LX3305 mid dose

Primary Outcome(s)

ACR20 Response at Week 12 [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Change From Baseline in C-reactive Protein (mg/L) at Week 12 [Time Frame: Baseline and 12 weeks]

ACR70 Response at Week 12 [Time Frame: Baseline and 12 weeks]

Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12 [Time Frame: Baseline and 12 weeks]

Hybrid ACR Response at Week 12 [Time Frame: Baseline and 12 weeks]

ACR50 Response at Week 12 [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

Protocol LX3305.1-201-RA

LX3305.201, LX2931

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00903383