Phase
Condition
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Dermatomyositis (Connective Tissue Disease)
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult subjects, aged 18 to 75 years
Active rheumatoid arthritis (RA), class I to III (defined by the American College ofRheumatology), diagnosed at least 3 months prior to Screening
Minimum of 4 swollen joints (at Screening and Day 1), minimum of 4 tender joints (atScreening and Day 1), and serum C-reactive protein (CRP) level >1.2x the upper limitof normal and/or elevated erythrocyte sedimentation rate (ESR)
If receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated forat least 6 weeks prior to Screening and currently receiving a stable dose ofmethotrexate (MTX) with a stable route of administration, and have no plans to changeMTX dose during the study
Ability to give written informed consent
Exclusion
Exclusion Criteria:
Women who are pregnant or nursing
RA diagnosis prior to 16 years of age (juvenile RA)
Intra-articular and/or parenteral corticosteroids within 4 weeks of study Day 1
Receipt of live vaccine within 4 weeks prior to Day 1
Major surgical procedure within 8 weeks prior to Day 1
Blood donation within 4 weeks prior to Day 1
Any systemic inflammatory condition
History of bleeding diathesis
History of medically significant opportunistic infection
History of drug or alcohol abuse within 3 years prior to Day 1
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)
Any clinically significant laboratory test results, in the opinion of the investigator
Use of any investigational agent or participation in an investigative trial within 30days of Day 1
Concurrent use of any biologic agent for the treatment of RA or concomitant diseasemodifying antirheumatoid drugs (other than MTX, hydroxychloroquine, leflunomide, andsulfasalazine - at stables doses for 8 weeks)
Study Design
Connect with a study center
Lexicon Investigational Site
Dallas, Texas 75231
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.