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

Sponsored by:	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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:	104
Study Start Date:	July 2009
Estimated Primary Completion Date:	June 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

Contacts

Contact: Barbara Brooks, Clinical Project Manager

281-863-3377

Locations

United States, Texas
Metroplex Clinical Research Center	Recruiting
Dallas, Texas, United States, 75235

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 )
Study ID Numbers:	Protocol LX3305.1-201-RA, LX3305.201, LX2931
Study First Received:	May 14, 2009
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00903383 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Folate
Rheumatic Diseases
Folinic Acid
Folic Acid Antagonists

Immunosuppressive Agents
Vitamin B9
Folic Acid
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 10, 2009