Phase
Condition
Bone Diseases
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR)-classification criteria or the new American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010-classification criteria and has a disease duration for a minimum of 3 months.
Subjects must be naïve to biologic therapy.
Subject must meet the following criteria for the joint assessment: • At least 6swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.
Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not onmethotrexate at baseline must remain without methotrexate throughout the study.Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior toWeek 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapyother than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10mg) must discontinue it for at least 28 days before the first dose of investigationalproduct at Week 0 (Day 1).
Female subjects are either not of childbearing potential, defined as postmenopausalfor at least 1 year or surgically sterile (bilateral tubal ligation, bilateraloophorectomy and/or hysterectomy), or are practicing at least 1 of the followingmethods of birth control throughout the study and for at least 150 days after the lastdose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterinedevice (IUD). • Hormonal contraceptives for 90 days prior to study drugadministration. • Vasectomized partner(s).
Subjects must be able and willing to self-administer subcutaneous (SC) injections orhave a qualified person available to administer subcutaneous (SC) injections.
Subject is judged to be in good general health as determined by the PrincipalInvestigator based upon the results of medical history, physical examination,laboratory profile, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performedduring Screening.
Subject has a negative Tuberculosis (TB) screening assessment (including a (PurifiedProtein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test orequivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) atScreening. If a subject has evidence of a latent Tuberculosis (TB) infection, thesubject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB)therapy or have documented completion of a course of anti-Tuberculosis (TB) therapyprior to Baseline.
Subjects must be willing to provide written consent and to comply with therequirements of this study protocol.
Exclusion
Exclusion Criteria:
Subject has been treated with intra-articular or parenteral administration ofcorticosteroids in the preceding 4 weeks from Baseline visit. Inhaled corticosteroidsfor stable medical conditions are allowed. Oral of less than or equal to 10 mg/dprednisone equivalent are allowed.
Subject has been treated with any investigational drug of a chemical or biologicalnature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drugprior to Baseline Visit.
Subject has a history of acute inflammatory joint disease of different origin otherthan Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriaticarthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or anyarthritis with onset prior to age 17 years).
Known hypersensitivity to adalimumab or its excipients.
Subject currently uses or plans to use anti-retroviral therapy at any time during thestudy.
History of demyelinating disease (including myelitis) or neurologic symptomssuggestive of demyelinating disease.
History of invasive infection (e.g., listeriosis and histoplasmosis), humanimmunodeficiency syndrome (HIV).
Chronic recurring infections or active Tuberculosis (TB).
History of moderate to severe congestive heart failure (New York Heart Association (NYHA) class III or IV), recent cerebrovascular accident and any other conditionwhich, in the opinion of the investigator, would put the subject at risk byparticipation in the protocol.
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) otherthan a successfully treated non-metastatic cutaneous squamous cell or basal cellcarcinoma or localized carcinoma in situ of the cervix.
Subject received any live vaccine within 3 months prior to study drug administration.
Subject has a history of clinically significant hematologic (e.g., severe anemia,leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis,hepatitis).
Positive pregnancy test at Screening or Baseline.
Subject is considered by the investigator, for any reason, to be unsuitable candidatefor the study
Study Design
Connect with a study center
Site Reference ID/Investigator# 75100
Brussels, 1200
BelgiumSite Not Available
Site Reference ID/Investigator# 75101
Liege, 4000
BelgiumSite Not Available
Site Reference ID/Investigator# 75104
Brno, 638 00
Czech RepublicSite Not Available
Site Reference ID/Investigator# 76788
Prague 2, 128 50
Czech RepublicSite Not Available
Site Reference ID/Investigator# 75102
Uherske Hradiste, 686 01
Czech RepublicSite Not Available
Site Reference ID/Investigator# 75103
Zlin, 760 01
Czech RepublicSite Not Available
Site Reference ID/Investigator# 75106
Berlin, 13125
GermanySite Not Available
Site Reference ID/Investigator# 78014
Ratingen, 40882
GermanySite Not Available
Site Reference ID/Investigator# 75079
Caguas, 00725
Puerto RicoSite Not Available
Site Reference ID/Investigator# 75078
Vega Baja, 00693
Puerto RicoSite Not Available
Site Reference ID/Investigator# 76787
Bucharest, 020475
RomaniaSite Not Available
Site Reference ID/Investigator# 75978
Cluj-Napoca, 400006
RomaniaSite Not Available
Site Reference ID/Investigator# 76433
Ploiesti, 100337
RomaniaSite Not Available
Site Reference ID/Investigator# 76934
Banska Bystrica, 97405
SlovakiaSite Not Available
Site Reference ID/Investigator# 76935
Senica, 905 01
SlovakiaSite Not Available
Site Reference ID/Investigator# 76682
Zilina, 010 01
SlovakiaSite Not Available
Site Reference ID/Investigator# 75073
Mesa, Arizona 85202
United StatesSite Not Available
Site Reference ID/Investigator# 75073
Paradise Valley, Arizona 85253
United StatesSite Not Available
Site Reference ID/Investigator# 75077
Hemet, California 92543
United StatesSite Not Available
Site Reference ID/Investigator# 75076
Wichita, Kansas 67203
United StatesSite Not Available
Site Reference ID/Investigator# 75075
Clifton, New Jersey 07012
United StatesSite Not Available
Site Reference ID/Investigator# 83133
Philadelphia, Pennsylvania 19152
United StatesSite Not Available
Site Reference ID/Investigator# 75074
Charleston, South Carolina 29406
United StatesSite Not Available

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