Phase
Condition
Rheumatoid Arthritis
Joint Injuries
Bone Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9tender joints
Subjects must have received at least one prior DMARD besides MTX, but may have hadefficacy failures on no more than four standard DMARDs other than MTX
Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTXfor at least 4 weeks prior to screening visit
Age 18 years and older
Exclusion
Exclusion Criteria:
Prior treatment with any TNF antagonist, including adalimumab
History of clinically significant drug or alcohol abuse in the previous year, iv drugabuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,andany malignancy with the exception of successfully treated non-metastatic basal-cellcarcinoma of the skin.
Subjects may not have been administered a live vaccine within three months prior tostudy drug administration or during the study, treatment with any otherinvestigational agent within 30 days or 5 half-lives of the agent, whichever islonger, prior to the screening evaluation, treatment with any investigational biologicagent, including anti-CD4 antibody, within 6 months prior to the screening evaluation,prior treatment with any TNF antagonist, including Adalimumab, prior exposure toalkylating agents such as chlorambucil or cyclophosphamide.
Chest X-ray with calcified granuloma and/or pleural scarring
Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours
Unstable ischemic heart disease, active inflammatory bowel disease, active pepticulcer disease, recent stroke (within 3 months of the screening evaluation) or anypoorly controlled medical condition
Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeksprior to screening evaluation
Female who is pregnant or breast-feeding.