Rheumatoid Arthritis
Conditions
Keywords
On label Humira users, Pain, Rheumatoid Arthritis,
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.
Interventions
BIOLOGICALAdalimumab
Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Injection Site Pain on a Visual Analogue Scale (VAS) | Immediately after injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale | 10 minutes and 30 minutes after injection | Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed. |
| Percentage of Participants With no Erythema in the Draize Scale | 10 minutes and 30 minutes after injection | Erythema (redness) was assessed. |
| Mean Injection Site Pain on a Visual Analogue Scale (VAS) | 15 minutes post injection | 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. |
| Percentage of Participants With no Pruritus in the Draize Scale | 10 minutes and 30 minutes after injection | Pruritus (itching) was assessed. |
| Number of Participants With Adverse Events (AEs) | 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. | 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. |
| Percentage of Participants With no Edema in the Draize Scale | 10 minutes and 30 minutes after injection | Edema (swelling) was assessed. |
Countries
Belgium, Czechia
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Current Formulation Adalimumab/New Formulation of Adalimumab First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe. | 31 |
| New Formulation of Adalimumab/Current Formulation Adalimumab First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe. | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse event and withdrawal by subject | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Current Formulation Adalimumab/New Formulation of Adalimumab | New Formulation of Adalimumab/Current Formulation Adalimumab | Total |
|---|---|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 12.57 | 58.6 years STANDARD_DEVIATION 13.53 | 54.8 years STANDARD_DEVIATION 13.49 |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 63 | 1 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 62 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Current Formulation Adalimumab | Mean Injection Site Pain on a Visual Analogue Scale (VAS) | 3.3 cm | Standard Deviation 2.11 |
| New Formulation of Adalimumab | Mean Injection Site Pain on a Visual Analogue Scale (VAS) | 1.6 cm | Standard Deviation 2.09 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Current Formulation Adalimumab | Mean Injection Site Pain on a Visual Analogue Scale (VAS) | 1.0 cm | Standard Deviation 1.52 |
| New Formulation of Adalimumab | Mean Injection Site Pain on a Visual Analogue Scale (VAS) | 0.9 cm | Standard Deviation 1.66 |
Secondary
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.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Current Formulation Adalimumab | Number of Participants With Adverse Events (AEs) | 2 participants |
| New Formulation of Adalimumab | Number of Participants With Adverse Events (AEs) | 1 participants |
Secondary
Percentage of Participants With no Edema in the Draize Scale
Edema (swelling) was assessed.
Time frame: 10 minutes and 30 minutes after injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Current Formulation Adalimumab | Percentage of Participants With no Edema in the Draize Scale | 10 minutes | 80.6 Percentage of Participants |
| Current Formulation Adalimumab | Percentage of Participants With no Edema in the Draize Scale | 30 minutes | 85.5 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Edema in the Draize Scale | 10 minutes | 83.9 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Edema in the Draize Scale | 30 minutes | 85.5 Percentage of Participants |
Secondary
Percentage of Participants With no Erythema in the Draize Scale
Erythema (redness) was assessed.
Time frame: 10 minutes and 30 minutes after injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Current Formulation Adalimumab | Percentage of Participants With no Erythema in the Draize Scale | 30 minutes | 75.8 Percentage of Participants |
| Current Formulation Adalimumab | Percentage of Participants With no Erythema in the Draize Scale | 10 minutes | 69.4 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Erythema in the Draize Scale | 10 minutes | 64.5 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Erythema in the Draize Scale | 30 minutes | 72.6 Percentage of Participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Current Formulation Adalimumab | Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale | 10 minutes | 91.9 Percentage of Participants |
| Current Formulation Adalimumab | Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale | 30 minutes | 98.4 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale | 10 minutes | 96.8 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale | 30 minutes | 98.4 Percentage of Participants |
Secondary
Percentage of Participants With no Pruritus in the Draize Scale
Pruritus (itching) was assessed.
Time frame: 10 minutes and 30 minutes after injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Current Formulation Adalimumab | Percentage of Participants With no Pruritus in the Draize Scale | 10 minutes | 100 Percentage of Participants |
| Current Formulation Adalimumab | Percentage of Participants With no Pruritus in the Draize Scale | 30 minutes | 98.4 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Pruritus in the Draize Scale | 10 minutes | 98.4 Percentage of Participants |
| New Formulation of Adalimumab | Percentage of Participants With no Pruritus in the Draize Scale | 30 minutes | 98.4 Percentage of Participants |