Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

Completed · Phase 3

Conditions studied: Early Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT01185301

Run by

AbbVie (prior sponsor, Abbott)

People needed

395

Starts

2010-10-01

Expected to finish

2012-09-01

Last updated by the study team

2013-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Disease Activity Score of C-reactive Protein (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)
• 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)
• 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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 41962 — Mesa, Arizona, United States
• Site Reference ID/Investigator# 39260 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 45323 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 38912 — Hemet, California, United States
• Site Reference ID/Investigator# 39673 — Victorville, California, United States
• Site Reference ID/Investigator# 38909 — Jacksonville, Florida, United States
• Site Reference ID/Investigator# 40422 — Miami, Florida, United States
• Site Reference ID/Investigator# 38910 — Sarasota, Florida, United States
• Site Reference ID/Investigator# 44284 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 38907 — Gainesville, Georgia, United States
• Site Reference ID/Investigator# 38972 — Lawrenceville, Georgia, United States
• Site Reference ID/Investigator# 39670 — Rock Island, Illinois, United States
• Site Reference ID/Investigator# 42282 — Springfield, Illinois, United States
• Site Reference ID/Investigator# 38911 — Wichita, Kansas, United States
• Site Reference ID/Investigator# 39672 — Covington, Louisiana, United States
• Site Reference ID/Investigator# 42204 — Omaha, Nebraska, United States
• Site Reference ID/Investigator# 40651 — Clifton, New Jersey, United States
• Site Reference ID/Investigator# 41422 — Freehold, New Jersey, United States
• Site Reference ID/Investigator# 41424 — The Bronx, New York, United States
• Site Reference ID/Investigator# 40463 — Greenville, North Carolina, United States
• Site Reference ID/Investigator# 42202 — Columbus, Ohio, United States
• Site Reference ID/Investigator# 44282 — Norman, Oklahoma, United States
• Site Reference ID/Investigator# 41423 — Duncansville, Pennsylvania, United States
• Site Reference ID/Investigator# 38971 — Charleston, South Carolina, United States
• Site Reference ID/Investigator# 38973 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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