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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01502423




Registration number
NCT01502423
Ethics application status
Date submitted
1/12/2011
Date registered
30/12/2011
Date last updated
20/02/2014

Titles & IDs
Public title
A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
Scientific title
A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis
Secondary ID [1] 0 0
2011-003953-25
Secondary ID [2] 0 0
M11-964
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Adalimumab

Active Comparator: Current formulation adalimumab - One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe

Experimental: New formulation of adalimumab - One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe


Other interventions: Adalimumab
Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Immediately after injection.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
15 minutes post injection
Secondary outcome [2] 0 0
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale - Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.
Timepoint [2] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [3] 0 0
Percentage of Participants With no Erythema in the Draize Scale - Erythema (redness) was assessed.
Timepoint [3] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [4] 0 0
Percentage of Participants With no Edema in the Draize Scale - Edema (swelling) was assessed.
Timepoint [4] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [5] 0 0
Percentage of Participants With no Pruritus in the Draize Scale - Pruritus (itching) was assessed.
Timepoint [5] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
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 that participant signed the informed consent.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 63354 - Malvern East
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 63355 - Maroochydore
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 63353 - Shenton Park
Recruitment postcode(s) [1] 0 0
3145 - Malvern East
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Hamilton
Country [2] 0 0
Canada
State/province [2] 0 0
Winnipeg
Country [3] 0 0
Germany
State/province [3] 0 0
Munich
Country [4] 0 0
Germany
State/province [4] 0 0
Ostseebad Damp

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
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 three countries, Australia (3 sites), Canada (2 sites), and
Germany (2 sites).
Trial website
https://clinicaltrials.gov/show/NCT01502423
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Payne, PhD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications