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A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab

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ClinicalTrials.gov Identifier: NCT01502423
Recruitment Status : Completed
First Posted : December 30, 2011
Results First Posted : February 20, 2014
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Adalimumab Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Current formulation adalimumab
One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
 Biological: Adalimumab
Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)
Other Names:
  • Humira
  • ABT-D2E7
Experimental: New formulation of adalimumab
One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
 Biological: Adalimumab
Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)
Other Names:
  • Humira
  • ABT-D2E7


Outcome Measures
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Primary Outcome Measures :
  1. Mean Injection Site Pain on a Visual Analogue Scale (VAS) [ Time Frame: 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 Outcome Measures :
  1. Mean Injection Site Pain on a Visual Analogue Scale (VAS) [ Time Frame: 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.

  2. Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale [ Time Frame: 10 minutes and 30 minutes after injection ]
    Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.

  3. Percentage of Participants With no Erythema in the Draize Scale [ Time Frame: 10 minutes and 30 minutes after injection ]
    Erythema (redness) was assessed.

  4. Percentage of Participants With no Edema in the Draize Scale [ Time Frame: 10 minutes and 30 minutes after injection ]
    Edema (swelling) was assessed.

  5. Percentage of Participants With no Pruritus in the Draize Scale [ Time Frame: 10 minutes and 30 minutes after injection ]
    Pruritus (itching) was assessed.

  6. Number of Participants With Adverse Events (AEs) [ 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502423


Locations
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Australia
Site Reference ID/Investigator# 63354
Malvern East, Australia, 3145
Site Reference ID/Investigator# 63355
Maroochydore, Australia, 4558
Site Reference ID/Investigator# 63353
Shenton Park, Australia, 6008
Canada
Site Reference ID/Investigator# 67105
Hamilton, Canada, L8N 2B6
Site Reference ID/Investigator# 64122
Winnipeg, Canada, R3A 1M3
Germany
Site Reference ID/Investigator# 63356
Munich, Germany, 80336
Site Reference ID/Investigator# 69242
Ostseebad Damp, Germany, 24351
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Andrew Payne, PhD AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01502423    
Other Study ID Numbers: M11-964
2011-003953-25 ( EudraCT Number )
First Posted: December 30, 2011    Key Record Dates
Results First Posted: February 20, 2014
Last Update Posted: February 20, 2014
Last Verified: January 2014
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
On label Humira users
Rheumatoid Arthritis
Pain
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents