Clinical trial NCT02986139: Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis
Official title: A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective was to assess the injection site pain associated with the new formulation of etanercept compared with commercial etanercept in adults with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) as measured by a visual analog scale (VAS).

Detailed description: This is a phase 3b, multicenter, randomized, double-blind, 2-period, 2-sequence crossover study in adults with RA or PsA who are naive to etanercept. The study will evaluate injection site pain associated with the commercial formulation of etanercept and the new formulation of etanercept immediately after injection of each formulation.The study will consist of a screening period of up to 14 days, a 2 week treatment period with a 30 day post treatment safety follow-up. Each dose will follow the recommended label dosing for adults with RA and PsA: 50 mg weekly (scheduled approximately 7 days apart).

Eligibility criteria: Inclusion Criteria

* Subject has provided informed consent prior to initiation of any study specific activities/procedures.
* Male or female subject is 18 years of age or older at time of signing the informed consent form.
* Subject has a diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on investigator judgment.
* Subject is naïve to etanercept.
* Subject is able to self-inject etanercept.

Exclusion Criteria

* Subject is diagnosed with Felty's syndrome.
* Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions.
* Subject has a history of clinically significant skin allergies
* Subject has a history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes.
* Subject has any active infection for which anti-infectives were indicated within 4 weeks prior to screening.
* Subject has had a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to first dose of investigational product.
* Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
* Subject has known alcohol addiction or dependency.
* Subject has positive hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B virus deoxyribonucleic acid (DNA) test) or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. (Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).
* Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
* Subject has known history of active tuberculosis.
* Subject has used biologic disease modifying agent (DMARD) less than or equal to 3 months prior to screening.
* If subject is receiving continuous treatment with acetaminophen, non-steroidal anti-inflammatory drug or tramadol, hydrocodone, oxycodone, codeine, and/or propoxyphene and the dose is within 4 hours before study visit and dose is not stable for ≥ 2 weeks before first dose of investigational product
* For subjects not on continuous analgesics, subject has taken the following within 4 hours before screening: acetaminophen, non-steroidal anti-inflammatory drugs, hydrocodone, codeine, tramadol, propoxyphene, and/or oxycodone (unless in the form of OxyContin). For subjects not on continuous analgesics, subject has taken OxyContin within 24 hours before screening.
* Subject has received live vaccines less than or equal to 4 weeks prior to first dose of investigational product.
* Subject has laboratory abnormalities during screening.
* Estimated creatinine clearance less than 50 mL/min.
* Subject has any other laboratory abnormality, which, in the opinion of the investigator poses a safety risk, will prevent the subject from completing the study, or will interfere with the interpretation of the study results.
* Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
* Other investigational procedures while participating in this study.
* Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment and/or within 4 weeks after the last dose of etanercept.
* Women of child-bearing potential with a positive pregnancy test.
* Women of child-bearing potential who are unwilling to practice true sexual abstinence or unwilling to use 1 of the following effective birth control methods during treatment and for an additional 4 weeks after the last dose of etanercept.

Primary outcomes:
measure: Injection Site Pain
timeFrame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study
Secondary outcomes:
measure: Injection Site Pain by Disease Indication
timeFrame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study
measure: Number of Participants With Adverse Events
timeFrame: From first dose of etanercept to 30 days after the last dose; 38 days.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: El Cajon
country: United States
facility: Research Site
state: California
city: Lomita
country: United States
facility: Research Site
state: California
city: Sherman Oaks
country: United States
facility: Research Site
state: California
city: Thousand Oaks
country: United States
facility: Research Site
state: California
city: Cutler Bay
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Doral
country: United States
facility: Research Site
state: Florida
city: Largo
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Winter Haven
country: United States
facility: Research Site
state: Florida
city: Quincy
country: United States
facility: Research Site
state: Illinois
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: Bay City
country: United States
facility: Research Site
state: Michigan
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Freehold
country: United States
facility: Research Site
state: New Jersey
city: Smithtown
country: United States
facility: Research Site
state: New York
city: Middleburg Heights
country: United States
facility: Research Site
state: Ohio
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Mesquite
country: United States
facility: Research Site
state: Texas
city: The Woodlands
country: United States
facility: Research Site
state: Texas
city: Bothell
country: United States
facility: Research Site
state: Washington
city: South Charleston
country: United States
facility: Research Site
state: West Virginia
city: Ponce
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Cohen S, Samad A, Karis E, Stolshek BS, Trivedi M, Zhang H, Aras GA, Kricorian G, Chung JB. Decreased Injection Site Pain Associated with Phosphate-Free Etanercept Formulation in Rheumatoid Arthritis or Psoriatic Arthritis Patients: A Randomized Controlled Trial. Rheumatol Ther. 2019 Jun;6(2):245-254. doi: 10.1007/s40744-019-0152-8. Epub 2019 Mar 27.