Status:
COMPLETED
A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stab...
Detailed Description
61 participants were randomized, and 60 received at least one dose of the study drug. One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm of the...
Eligibility Criteria
Inclusion
- Male or female subject age 18 years or older, who requires Humira 40 mg SC every other week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance with the local Humira label.
- Subject must be a current, on-label user of Humira who rates his/her average Humira injection site related pain as at least 3 cm on a pain Visual Analogue Scale and has had at least 6 consecutive doses of Humira prior to Screening, or a biologic naïve subject who requires initiation of on-label treatment with Humira.
- Subject has diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised ACR classification criteria or the ACR/EULAR 2010 criteria,
- Female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least one method of birth control throughout the study and for at least 70 days after the last dose of study drug.
- All female subjects of childbearing potential must have a negative test for pregnancy on a serum sample at Screening and prior to study drug dosing on a urine sample obtained at Visit 1.
Exclusion
- Subject has been treated with any investigational drug of a chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 1.
- Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days 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 symptoms suggestive of demyelinating disease.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01502423
Start Date
January 1 2012
End Date
November 1 2012
Last Update
February 20 2014
Active Locations (7)
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1
Site Reference ID/Investigator# 63354
Malvern East, Australia, 3145
2
Site Reference ID/Investigator# 63355
Maroochydore, Australia, 4558
3
Site Reference ID/Investigator# 63353
Shenton Park, Australia, 6008
4
Site Reference ID/Investigator# 67105
Hamilton, Canada, L8N 2B6