The purpose of this study is to determine the effects of different doses of methotrexate
(MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 2010
and has a disease duration of less than 1 year from diagnosis by a licensed health
care provider
- Subject must meet the following criteria:
1. Disease Activity Score of C-reactive Protein (DAS28[CRP]) ≥ 3. 2 (at the Baseline
visit only)
2. At least 6 swollen joints out of 66 assessed (at the Screening and Baseline
visits)
3. At least 8 tender joints out of 68 assessed (at the Screening and Baseline
visits)
4. C-reactive protein (CRP) ≥ 1. 5 mg/dL (at the Screening visit only), or
erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline
visits)
5. Fulfill at least one of the following three criteria: Rheumatoid Factor (RF)
positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide
(anti-CCP) antibody positive
- 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: hepatitis B surface antigen (HBs Ag) positive (+) or detected
sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (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
Site Reference ID/Investigator# 44924, Buenos Aires C1055AAF, Argentina
Site Reference ID/Investigator# 44926, Buenos Aires C1425DTG, Argentina
Site Reference ID/Investigator# 44925, Rosario, Santa Fe S2000PBJ, Argentina
Site Reference ID/Investigator# 47302, San Juan J5402DIL, Argentina
Site Reference ID/Investigator# 44928, Graz 80360, Austria
Site Reference ID/Investigator# 44927, Vienna 1100, Austria
Site Reference ID/Investigator# 44930, Vienna 1090, Austria
Site Reference ID/Investigator# 44934, Brussels 1200, Belgium
Site Reference ID/Investigator# 44935, Genk 3600, Belgium
Site Reference ID/Investigator# 44933, Gilly 6060, Belgium
Site Reference ID/Investigator# 44932, Liege 4000, Belgium
Site Reference ID/Investigator# 43783, Edmonton T5M 0H4, Canada
Site Reference ID/Investigator# 43782, Winnipeg R3A 1M3, Canada
Site Reference ID/Investigator# 44937, Brno 63800, Czech Republic
Site Reference ID/Investigator# 48962, Ceske Budejovice 37021, Czech Republic
Site Reference ID/Investigator# 44939, Ostrava 72200, Czech Republic
Site Reference ID/Investigator# 44936, Prague 2 128 50, Czech Republic
Site Reference ID/Investigator# 44938, Uherske Hradiste 686 01, Czech Republic
Site Reference ID/Investigator# 48963, Zlin 76001, Czech Republic
Site Reference ID/Investigator# 44945, Berlin-Buch 13125, Germany
Site Reference ID/Investigator# 44941, Berlin 10117, Germany
Site Reference ID/Investigator# 44942, Munich 80336, Germany
Site Reference ID/Investigator# 44944, Ratingen 40882, Germany
Site Reference ID/Investigator# 44943, Zerbst 39261, Germany
Site Reference ID/Investigator# 44946, Bydgoszcz 85168, Poland
Site Reference ID/Investigator# 44982, Lodz 90-242, Poland
Site Reference ID/Investigator# 46584, Torun 87-100, Poland
Site Reference ID/Investigator# 44983, Warsaw 02-256, Poland
Site Reference ID/Investigator# 44984, Warsaw 02-118, Poland
Site Reference ID/Investigator# 38975, Caguas 00725, Puerto Rico
Site Reference ID/Investigator# 38916, San Juan 00936-8344, Puerto Rico
Site Reference ID/Investigator# 39693, San Juan 00936-5067, Puerto Rico
Site Reference ID/Investigator# 40122, San Juan 00906-6312, Puerto Rico
Site Reference ID/Investigator# 39692, Vega Baja 00693, Puerto Rico
Site Reference ID/Investigator# 44947, A Coruna 15006, Spain
Site Reference ID/Investigator# 44987, Elche (Alicante) 03203, Spain
Site Reference ID/Investigator# 44948, Oviedo (Asturias) 33006, Spain
Site Reference ID/Investigator# 47782, Valencia 46026, Spain
Site Reference ID/Investigator# 38973, Huntsville, Alabama 35801, United States
Site Reference ID/Investigator# 41962, Mesa, Arizona 85202, United States
Site Reference ID/Investigator# 39260, Phoenix, Arizona 85031, United States
Site Reference ID/Investigator# 45323, Little Rock, Arkansas 72205, United States
Site Reference ID/Investigator# 38912, Hemet, California 92543, United States
Site Reference ID/Investigator# 39673, Victorville, California 92395, United States
Site Reference ID/Investigator# 38909, Jacksonville, Florida 32209, United States
Site Reference ID/Investigator# 40422, Miami, Florida 33169, United States
Site Reference ID/Investigator# 38910, Sarasota, Florida 34239, United States
Site Reference ID/Investigator# 44284, Atlanta, Georgia 30312, United States
Site Reference ID/Investigator# 38907, Gainesville, Georgia 30501, United States
Site Reference ID/Investigator# 38972, Lawrenceville, Georgia 30045, United States
Site Reference ID/Investigator# 39670, Rock Island, Illinois 61201, United States
Site Reference ID/Investigator# 42282, Springfield, Illinois 62704, United States
Site Reference ID/Investigator# 38911, Wichita, Kansas 67203, United States
Site Reference ID/Investigator# 39672, Covington, Louisiana 70433, United States
Site Reference ID/Investigator# 42204, Omaha, Nebraska 68114, United States
Site Reference ID/Investigator# 40651, Clifton, New Jersey 07012, United States
Site Reference ID/Investigator# 41422, Freehold, New Jersey 07728, United States
Site Reference ID/Investigator# 41424, Bronx, New York 10467, United States
Site Reference ID/Investigator# 40463, Greenville, North Carolina 27834, United States
Site Reference ID/Investigator# 42202, Columbus, Ohio 43213, United States
Site Reference ID/Investigator# 44282, Norman, Oklahoma 73069, United States
Site Reference ID/Investigator# 41423, Duncansville, Pennsylvania 16635, United States
Site Reference ID/Investigator# 38971, Charleston, South Carolina 29406, United States
Site Reference ID/Investigator# 39666, Jackson, Tennessee 38305, United States
Site Reference ID/Investigator# 39643, Dallas, Texas 75231, United States
Site Reference ID/Investigator# 45325, Dallas, Texas 75246, United States
Site Reference ID/Investigator# 52042, Houston, Texas 77074, United States
Site Reference ID/Investigator# 40602, Seattle, Washington 98101, United States