Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

Last updated: January 23, 2014
Sponsor: AbbVie (prior sponsor, Abbott)
Overall Status: Completed

Phase

2

Condition

Bone Diseases

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01561313
M12-783
2011-002275-41
  • Ages > 18
  • All Genders

Study 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 stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3 sites).

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

Total Participants: 64
Study Start date:
March 01, 2012
Estimated Completion Date:
November 30, 2012

Study Description

64 participants were randomized, 63 received at least one dose of the study drug, and 62 participants were analyzed for injection site-related pain. 63 participants were analyzed for other safety analyses. Two participants, who were randomized to the Current formulation adalimumab/New formulation of adalimumab arm of the study were excluded from the analysis of injection site-related pain. One participant received one dose of study drug and discontinued because of an adverse event, while the other discontinued before receiving any study drug.

Connect with a study center

  • Site Reference ID/Investigator# 63357

    Genk, 3600
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 63359

    Ghent, 9000
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 63360

    Ghent, 9000
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 63358

    Hasselt, 3500
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 63359

    Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 63363

    Brno, 63800
    Czech Republic

    Site Not Available

  • Site Reference ID/Investigator# 63362

    Prague 2, 128 50
    Czech Republic

    Site Not Available

  • Site Reference ID/Investigator# 63361

    Uherske Hradiste, 686 01
    Czech Republic

    Site Not Available

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