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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)
Site Reference ID/Investigator# 63357
Genk, Belgium
Site Reference ID/Investigator# 63359
Ghent, Belgium
Site Reference ID/Investigator# 63360
Ghent, Belgium
Site Reference ID/Investigator# 63363
Brno, Czechia
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.
Time frame: Immediately after injection
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: 15 minutes post injection
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale
Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.
Time frame: 10 minutes and 30 minutes after injection
Percentage of Participants With no Erythema in the Draize Scale
Erythema (redness) was assessed.
Time frame: 10 minutes and 30 minutes after injection
Percentage of Participants With no Edema in the Draize Scale
Edema (swelling) was assessed.
Time frame: 10 minutes and 30 minutes after injection
Percentage of Participants With no Pruritus in the Draize Scale
Pruritus (itching) was assessed.
Time frame: 10 minutes and 30 minutes after injection
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
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Site Reference ID/Investigator# 63362
Prague, Czechia
Site Reference ID/Investigator# 63361
Uherské Hradiště, Czechia
Time frame: 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.