Expired Study
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Miami, Florida 33169


Purpose:

Study to Determine the Effects of Different Doses of Methotrexate (MTX) when taken with Adalimumab in Subjects with Early Rheumatoid Arthritis (RA).


Criteria:

Inclusion Criteria: - Male and female subjects at least 18 years of age - Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the 1987-revised American College of Rheumatology (ACR) classification criteria or the new ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2009 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider - Subject must meet the following criteria: DAS28(CRP) ≥3.2 at the Baseline Visit only - At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits), at least 8 tender joints out of 68 assessed at the Screening and Baseline visits) - Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening Exclusion Criteria: - Subject has previous exposure to any systemic biologic therapy including adalimumab - Subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (DMARDs) or with Methotrexate (MTX) - Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) - Subject has chronic arthritis diagnosed before age 17 years - History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB) - Hepatitis B virus (HB): HBs Ag (surface antigen) positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test - Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit. - Female subject who is pregnant or breast-feeding or considering becoming pregnant


NCT ID:

NCT01185301


Primary Contact:

Study Director
Dawn Carlson, MD
AbbVie


Backup Contact:

N/A


Location Contact:

Miami, Florida 33169
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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