Phase
Condition
Bone Diseases
Dermatomyositis (Connective Tissue Disease)
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subject age 18 years or older, who requires Humira 40 mg SC every otherweek (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordancewith the local Humira label.
Subject must be a current, on-label user of Humira who rates his/her average Humirainjection site related pain as at least 3 cm on a pain Visual Analogue Scale and hashad at least 6 consecutive doses of Humira prior to Screening, or a biologic naïvesubject who requires initiation of on-label treatment with Humira.
Subject has diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised ACRclassification criteria or the ACR/EULAR 2010 criteria,
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 one method of birthcontrol throughout the study and for at least 70 days after the last dose of studydrug.
All female subjects of childbearing potential must have a negative test for pregnancyon a serum sample at Screening and prior to study drug dosing on a urine sampleobtained at Visit 1.
Exclusion
Exclusion Criteria:
Subject has been treated with any investigational drug of a chemical or biologicnature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drugprior to Visit 1.
Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30days prior to Visit 1 or oral anti-infectives within 14 days prior to Visit 1.
Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
Known hypersensitivity to adalimumab or its excipients.
History of demyelinating disease (including myelitis) or neurologic symptomssuggestive of demyelinating disease.
Study Design
Study Description
Connect with a study center
Site Reference ID/Investigator# 63357
Genk, 3600
BelgiumSite Not Available
Site Reference ID/Investigator# 63359
Ghent, 9000
BelgiumSite Not Available
Site Reference ID/Investigator# 63360
Ghent, 9000
BelgiumSite Not Available
Site Reference ID/Investigator# 63358
Hasselt, 3500
BelgiumSite Not Available
Site Reference ID/Investigator# 63359
Sint-Niklaas, 9100
BelgiumSite Not Available
Site Reference ID/Investigator# 63363
Brno, 63800
Czech RepublicSite Not Available
Site Reference ID/Investigator# 63362
Prague 2, 128 50
Czech RepublicSite Not Available
Site Reference ID/Investigator# 63361
Uherske Hradiste, 686 01
Czech RepublicSite Not Available

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