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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: LX3305 high dose; Drug: Placebo; Drug: LX3305 low dose; Drug: LX3305 mid dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00903383

Protocol LX3305.1-201-RA

LX3305.201, LX2931

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 4 patient groups, including a placebo group

Low Dose

Experimental group

Description:

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

Treatment:

Drug: LX3305 low dose

Mid Dose

Experimental group

Description:

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

Treatment:

Drug: LX3305 mid dose

High Dose

Experimental group

Description:

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

Treatment:

Drug: LX3305 high dose

Placebo

Placebo Comparator group

Description:

Matching placebo dosing with daily oral intake for 12 weeks

Treatment:

Drug: Placebo