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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Adalimumab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring On label Humira users, Pain, Rheumatoid Arthritis,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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# 63357
Site Reference ID/Investigator# 63359
Site Reference ID/Investigator# 63360
Site Reference ID/Investigator# 63363
Site Reference ID/Investigator# 63362
Site Reference ID/Investigator# 63361

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, with 0 representing no pain and 10 representing the worst possible pain.

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

NCT01561313

First Posted

March 21, 2012

Last Updated

January 23, 2014

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01561313

Brief Title

Crossover Study of 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

March 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

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 two countries, Belgium (3 sites) and the Czech Republic (3 sites).

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.

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, Pain, Rheumatoid Arthritis,

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

64 (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

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

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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# 63357

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Site Reference ID/Investigator# 63359

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Site Reference ID/Investigator# 63360

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Site Reference ID/Investigator# 63363

City

Brno

ZIP/Postal Code

63800

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 63362

City

Prague 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 63361

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czech Republic

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

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

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