Back to resultsA Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring On label Humira users, Rheumatoid Arthritis, Pain
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.
Sites / Locations
- Site Reference ID/Investigator# 63354
- Site Reference ID/Investigator# 63355
- Site Reference ID/Investigator# 63353
- Site Reference ID/Investigator# 67105
- Site Reference ID/Investigator# 64122
- Site Reference ID/Investigator# 63356
- Site Reference ID/Investigator# 69242
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Current formulation adalimumab
New formulation of adalimumab
Arm Description
One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale
Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.
Percentage of Participants With no Erythema in the Draize Scale
Erythema (redness) was assessed.
Percentage of Participants With no Edema in the Draize Scale
Edema (swelling) was assessed.
Percentage of Participants With no Pruritus in the Draize Scale
Pruritus (itching) was assessed.
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.
Full Information
NCT ID
NCT01502423
First Posted
December 1, 2011
Last Updated
January 23, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01502423
Brief Title
A Crossover Study of the 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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
61 participants were randomized, and 60 received at least one dose of the study drug. One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm of the study, discontinued from the study and never received study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
On label Humira users, Rheumatoid Arthritis, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current formulation adalimumab
Arm Type
Active Comparator
Arm Description
One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
Arm Title
New formulation of adalimumab
Arm Type
Experimental
Arm Description
One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira, ABT-D2E7
Intervention Description
Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)
Primary Outcome Measure Information:
Title
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
Description
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.
Secondary Outcome Measure Information:
Title
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
Description
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.
Time Frame
15 minutes post injection
Title
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale
Description
Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.
Time Frame
10 minutes and 30 minutes after injection
Title
Percentage of Participants With no Erythema in the Draize Scale
Description
Erythema (redness) was assessed.
Time Frame
10 minutes and 30 minutes after injection
Title
Percentage of Participants With no Edema in the Draize Scale
Description
Edema (swelling) was assessed.
Time Frame
10 minutes and 30 minutes after injection
Title
Percentage of Participants With no Pruritus in the Draize Scale
Description
Pruritus (itching) was assessed.
Time Frame
10 minutes and 30 minutes after injection
Title
Number of Participants With Adverse Events (AEs)
Description
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 that participant signed the informed consent.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Payne, PhD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 63354
City
Malvern East
ZIP/Postal Code
3145
Country
Australia
Facility Name
Site Reference ID/Investigator# 63355
City
Maroochydore
ZIP/Postal Code
4558
Country
Australia
Facility Name
Site Reference ID/Investigator# 63353
City
Shenton Park
ZIP/Postal Code
6008
Country
Australia
Facility Name
Site Reference ID/Investigator# 67105
City
Hamilton
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
Site Reference ID/Investigator# 64122
City
Winnipeg
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Site Reference ID/Investigator# 63356
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Site Reference ID/Investigator# 69242
City
Ostseebad Damp
ZIP/Postal Code
24351
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27747583
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.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.
Learn more about this trial
A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
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