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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Adalimumab (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Andrew Payne, PhD, Study Director, Affiliation: AbbVie

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 na├»ve 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).

Clinical Details

Official title: A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Mean Injection Site Pain on a Visual Analogue Scale (VAS)

Secondary outcome:

Mean Injection Site Pain on a Visual Analogue Scale (VAS)

Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale

Percentage of Participants With no Erythema in the Draize Scale

Percentage of Participants With no Edema in the Draize Scale

Percentage of Participants With no Pruritus in the Draize Scale

Number of Participants With Adverse Events (AEs)

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Locations and Contacts

Site Reference ID/Investigator# 63357, Genk 3600, Belgium

Site Reference ID/Investigator# 63359, Ghent 9000, Belgium

Site Reference ID/Investigator# 63360, Ghent 9000, Belgium

Site Reference ID/Investigator# 63363, Brno 63800, Czech Republic

Site Reference ID/Investigator# 63362, Prague 2 128 50, Czech Republic

Site Reference ID/Investigator# 63361, Uherske Hradiste 686 01, Czech Republic

Additional Information

This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.

Starting date: March 2012
Last updated: January 23, 2014

Page last updated: August 23, 2015

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