Clinical trial NCT01561313: Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: On label Humira users
Pain
Rheumatoid Arthritis,
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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).

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 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.

Primary outcomes:
measure: Mean Injection Site Pain on a Visual Analogue Scale (VAS)
timeFrame: Immediately after injection
Secondary outcomes:
measure: Mean Injection Site Pain on a Visual Analogue Scale (VAS)
timeFrame: 15 minutes post injection
measure: Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale
timeFrame: 10 minutes and 30 minutes after injection
measure: Percentage of Participants With no Erythema in the Draize Scale
timeFrame: 10 minutes and 30 minutes after injection
measure: Percentage of Participants With no Edema in the Draize Scale
timeFrame: 10 minutes and 30 minutes after injection
measure: Percentage of Participants With no Pruritus in the Draize Scale
timeFrame: 10 minutes and 30 minutes after injection
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Site Reference ID/Investigator# 63357
city: Ghent
country: Belgium
facility: Site Reference ID/Investigator# 63359
city: Ghent
country: Belgium
facility: Site Reference ID/Investigator# 63360
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 63363
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 63362
city: Uherske Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 63361
Study officials:
affiliation: AbbVie
name: Andrew Payne, PhD
role: STUDY_DIRECTOR
References:
citation: Nash P, Vanhoof J, Hall S, Arulmani U, Tarzynski-Potempa R, Unnebrink K, Payne AN, Cividino A. Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2016 Dec;3(2):257-270. doi: 10.1007/s40744-016-0041-3. Epub 2016 Aug 18.