NCT01502423

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 20, 2014

Completed
Last Updated

February 20, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

December 1, 2011

Results QC Date

November 7, 2013

Last Update Submit

January 23, 2014

Conditions

Rheumatoid Arthritis

Keywords

On label Humira usersRheumatoid ArthritisPain

Outcome Measures

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.

    Immediately after injection.

Secondary Outcomes (6)

  • Mean Injection Site Pain on a Visual Analogue Scale (VAS)

    15 minutes post injection

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

    10 minutes and 30 minutes after injection

  • Percentage of Participants With no Erythema in the Draize Scale

    10 minutes and 30 minutes after injection

  • Percentage of Participants With no Edema in the Draize Scale

    10 minutes and 30 minutes after injection

  • Percentage of Participants With no Pruritus in the Draize Scale

    10 minutes and 30 minutes after injection

  • +1 more secondary outcomes

Study Arms (2)

Current formulation adalimumab

ACTIVE COMPARATOR

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

Biological: Adalimumab

New formulation of adalimumab

EXPERIMENTAL

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

Biological: Adalimumab

Interventions

AdalimumabBIOLOGICAL

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

Also known as: Humira, ABT-D2E7
Current formulation adalimumabNew formulation of adalimumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Site Reference ID/Investigator# 63354

Malvern East, 3145, Australia

Location

Site Reference ID/Investigator# 63355

Maroochydore, 4558, Australia

Location

Site Reference ID/Investigator# 63353

Shenton Park, 6008, Australia

Location

Site Reference ID/Investigator# 67105

Hamilton, L8N 2B6, Canada

Location

Site Reference ID/Investigator# 64122

Winnipeg, R3A 1M3, Canada

Location

Site Reference ID/Investigator# 63356

Munich, 80336, Germany

Location

Site Reference ID/Investigator# 69242

Ostseebad Damp, 24351, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27747583DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie (prior sponsor, Abbott)
800-633-9110

Study Officials

  • Andrew Payne, PhD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 30, 2011

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 20, 2014

Results First Posted

February 20, 2014

Record last verified: 2014-01

Locations

AU(3)DE(2)CA(2)