Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate - Full Text View

Sponsor:	Lexicon Pharmaceuticals
Information provided by:	Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00903383

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: LX3305 low dose Drug: LX3305 mid dose Drug: LX3305 high dose Drug: Placebo	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability (physical examinations, monitoring of adverse events, clinical laboratory tests, vital signs measurements, and ECGs). [ Time Frame: Serially over the 12-week treatment period and at 2 weeks post-dose follow up ] [ Designated as safety issue: No ]
Efficacy (ACR20) [ Time Frame: Serially over the 12-week treatment period and at 2 weeks post-dose follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR20, ACR50, ACR70, Hybrid ACR response measure, DAS28, and biomarkers of interest [ Time Frame: Serially over the 12-week treatment period and at 2 weeks post-dose follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2009
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low Dose: Experimental A low dose of LX3305; daily oral intake for 12 weeks	Drug: LX3305 low dose A low dose of LX3305; daily oral intake for 12 weeks
Mid Dose: Experimental A mid dose of LX3305; daily oral intake for 12 weeks	Drug: LX3305 mid dose A mid dose of LX3305; daily oral intake for 12 weeks
High Dose: Experimental A high dose of LX3305; daily oral intake for 12 weeks	Drug: LX3305 high dose A high dose of LX3305; daily oral intake for 12 weeks
Placebo: Placebo Comparator Matching placebo dosing with daily oral intake for 12 weeks	Drug: Placebo Matching placebo dosing with daily oral intake for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903383

Show 38 Study Locations

Sponsors and Collaborators

Lexicon Pharmaceuticals

Investigators

Study Director:

Joel P. Freiman, MD, MPH

Lexicon Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Lexicon Pharmaceuticals, Inc. ( Joel P. Freiman, MD, MPH - Medical Director )
ClinicalTrials.gov Identifier:	NCT00903383 History of Changes
Other Study ID Numbers:	Protocol LX3305.1-201-RA, LX3305.201, LX2931
Study First Received:	May 14, 2009
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 31, 2010