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CompletedNCT01502423Updated Feb 20, 2014Results posted

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

A Phase 2 interventional study of Adalimumab in Rheumatoid Arthritis, sponsored by AbbVie (prior sponsor, Abbott). Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-20.

Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • On label Humira users
  • Rheumatoid Arthritis
  • Pain
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 61 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
61 participants (actual)

Study arms

  • Active comparator
    Current formulation adalimumab

    One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe

    Biological: Adalimumab

  • Experimental
    New formulation of adalimumab

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

    Biological: Adalimumab

Interventions

  • BiologicalAdalimumab

    Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)

    Also known as: Humira, ABT-D2E7

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after injection.

Secondary outcomes

  1. 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.

    Time frame: 15 minutes post injection

  2. Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale

    Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.

    Time frame: 10 minutes and 30 minutes after injection

  3. Percentage of Participants With no Erythema in the Draize Scale

    Erythema (redness) was assessed.

    Time frame: 10 minutes and 30 minutes after injection

  4. Percentage of Participants With no Edema in the Draize Scale

    Edema (swelling) was assessed.

    Time frame: 10 minutes and 30 minutes after injection

  5. Percentage of Participants With no Pruritus in the Draize Scale

    Pruritus (itching) was assessed.

    Time frame: 10 minutes and 30 minutes after injection

  6. 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.

    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.

07

Results

Posted Feb 20, 2014

Participant flow

Participant flow — Overall Study
MilestoneCurrent Formulation Adalimumab/New Formulation of AdalimumabNew Formulation of Adalimumab/Current Formulation Adalimumab
Started3130
Completed3129
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryMean 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.

Time frame:
Immediately after injection.
Reported as:
Mean · cm
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
cmCurrent Formulation AdalimumabNew Formulation of Adalimumab
Mean Injection Site Pain on a Visual Analogue Scale (VAS)4.2 ± 2.720.9 ± 1.44
SecondaryMean 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.

Time frame:
15 minutes post injection
Reported as:
Mean · cm
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
cmCurrent Formulation AdalimumabNew Formulation of Adalimumab
Mean Injection Site Pain on a Visual Analogue Scale (VAS)1.0 ± 1.610.4 ± 1.08
SecondaryPercentage of Participants With no Hemorrhage/Petechiae in the Draize Scale

Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.

Time frame:
10 minutes and 30 minutes after injection
Reported as:
Number · Percentage of Participants
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale
Percentage of ParticipantsCurrent Formulation AdalimumabNew Formulation of Adalimumab
10 minutes8090
30 minutes81.791.7
SecondaryPercentage of Participants With no Erythema in the Draize Scale

Erythema (redness) was assessed.

Time frame:
10 minutes and 30 minutes after injection
Reported as:
Number · Percentage of Participants
Percentage of Participants With no Erythema in the Draize Scale
Percentage of ParticipantsCurrent Formulation AdalimumabNew Formulation of Adalimumab
10 minutes5063.3
30 minutes6075
SecondaryPercentage of Participants With no Edema in the Draize Scale

Edema (swelling) was assessed.

Time frame:
10 minutes and 30 minutes after injection
Reported as:
Number · Percentage of Participants
Percentage of Participants With no Edema in the Draize Scale
Percentage of ParticipantsCurrent Formulation AdalimumabNew Formulation of Adalimumab
10 minutes9093.3
30 minutes91.795
SecondaryPercentage of Participants With no Pruritus in the Draize Scale

Pruritus (itching) was assessed.

Time frame:
10 minutes and 30 minutes after injection
Reported as:
Number · Percentage of Participants
Percentage of Participants With no Pruritus in the Draize Scale
Percentage of ParticipantsCurrent Formulation AdalimumabNew Formulation of Adalimumab
10 minutes98.395
30 minutes96.796.7
SecondaryNumber 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.

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.
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs)
participantsCurrent Formulation AdalimumabNew Formulation of Adalimumab
Number of Participants With Adverse Events (AEs)84

Adverse events

Collected over Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Current Formulation Adalimumab—0/60 (0%)8/60 (13.3%)
New Formulation of Adalimumab—0/60 (0%)4/60 (6.7%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventCurrent Formulation AdalimumabNew Formulation of Adalimumab
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations2/601/60
URINARY TRACT INFECTIONInfections and infestations2/600/60
CYSTGeneral disorders1/600/60
INJECTION SITE PRURITUSGeneral disorders0/601/60
INJECTION SITE REACTIONGeneral disorders0/601/60
LOWER RESPIRATORY TRACT INFECTIONInfections and infestations1/600/60
RESPIRATORY TRACT INFECTION VIRALInfections and infestations1/600/60
CONTUSIONInjury, poisoning and procedural complications1/600/60
POST-TRAUMATIC PAINInjury, poisoning and procedural complications0/601/60
UPPER LIMB FRACTUREInjury, poisoning and procedural complications1/600/60

Baseline characteristics

All analyses were based on the cITT population, which included all subjects who were randomized and completed both periods and received study drug in both periods of the study (N = 60).

Age, Continuous
Age, Continuous(years)Current Formulation Adalimumab/New Formulation of AdalimumabNew Formulation of Adalimumab/Current Formulation AdalimumabTotal
Mean58.3 ± 11.5654.4 ± 14.1156.4 ± 12.90
Sex: Female, Male
Sex: Female, Male(Participants)Current Formulation Adalimumab/New Formulation of AdalimumabNew Formulation of Adalimumab/Current Formulation AdalimumabTotal
Female242347
Male7613
08

Study locations

7 sites
  • Site Reference ID/Investigator# 63354
    Malvern East, 3145, Australia
  • Site Reference ID/Investigator# 63355
    Maroochydore, 4558, Australia
  • Site Reference ID/Investigator# 63353
    Shenton Park, 6008, Australia
  • Site Reference ID/Investigator# 67105
    Hamilton, L8N 2B6, Canada
  • Site Reference ID/Investigator# 64122
    Winnipeg, R3A 1M3, Canada
  • Site Reference ID/Investigator# 63356
    Munich, 80336, Germany
  • Site Reference ID/Investigator# 69242
    Ostseebad Damp, 24351, Germany
09

References and documents

Publications

  • 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. PubMed 27747583 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01502423
Lead sponsor
AbbVie (prior sponsor, Abbott)
Responsible party
Sponsor
First posted
Dec 30, 2011
Start date
Jan 2012
Primary completion
Nov 2012
Completion
Nov 2012
Results posted
Feb 20, 2014
Last update
Feb 20, 2014

Study contacts

Andrew Payne, PhD
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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