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

January 23, 2014 updated by: AbbVie (prior sponsor, Abbott)

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Site Reference ID/Investigator# 63357
      • Ghent, Belgium, 9000
        • Site Reference ID/Investigator# 63359
      • Ghent, Belgium, 9000
        • Site Reference ID/Investigator# 63360
  • Czech Republic
      • Brno, Czech Republic, 63800
        • Site Reference ID/Investigator# 63363
      • Prague 2, Czech Republic, 128 50
        • Site Reference ID/Investigator# 63362
      • Uherske Hradiste, Czech Republic, 686 01
        • Site Reference ID/Investigator# 63361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:
  • ABT-D2E7
  • Humira
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:
  • ABT-D2E7
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after injection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (ESTIMATE)

March 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-783
  • 2011-002275-41 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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