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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Adalimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current formulation adalimumab<br>One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe | Biological: Adalimumab<br>* Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)<br>* Other names: ABT-D2E7;|
| Experimental: New formulation of adalimumab<br>One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe | Biological: Adalimumab<br>* Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)<br>* Other names: ABT-D2E7;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 10 minutes and 30 minutes after injection | 
| Percentage of Participants With no Erythema in the Draize Scale | Erythema (redness) was assessed. | 10 minutes and 30 minutes after injection | 
| Percentage of Participants With no Edema in the Draize Scale | Edema (swelling) was assessed. | 10 minutes and 30 minutes after injection | 
| Percentage of Participants With no Pruritus in the Draize Scale | Pruritus (itching) was assessed. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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On label Humira users, Pain, Rheumatoid Arthritis,