Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis

NCT ID: NCT02986139

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-29
• Study Completion Date: 2017-10-09

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).

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Sequence AB

Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).

Group Type: EXPERIMENTAL

Commercial Formulation Etanercept

Intervention Type: DRUG

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.

New Formulation Etanercept

Intervention Type: DRUG

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.

Sequence BA

Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).

Group Type: EXPERIMENTAL

Commercial Formulation Etanercept

Intervention Type: DRUG

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.

New Formulation Etanercept

Intervention Type: DRUG

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.

Interventions

Commercial Formulation Etanercept

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.

Intervention Type: DRUG

New Formulation Etanercept

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.

Intervention Type: DRUG

Other Intervention Names

Enbrel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Birmingham, Alabama, United States

Research Site

El Cajon, California, United States

Research Site

Lomita, California, United States

Research Site

Sherman Oaks, California, United States

Research Site

Thousand Oaks, California, United States

Research Site

Cutler Bay, Florida, United States

Research Site

DeLand, Florida, United States

Research Site

Doral, Florida, United States

Research Site

Largo, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Winter Haven, Florida, United States

Research Site

Quincy, Illinois, United States

Research Site

Skokie, Illinois, United States

Research Site

Bay City, Michigan, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

Flowood, Mississippi, United States

Research Site

Kansas City, Missouri, United States

Research Site

Freehold, New Jersey, United States

Research Site

Smithtown, New York, United States

Research Site

Middleburg Heights, Ohio, United States

Research Site

Wyomissing, Pennsylvania, United States

Research Site

Orangeburg, South Carolina, United States

Research Site

Dallas, Texas, United States

Research Site

El Paso, Texas, United States

Research Site

Houston, Texas, United States

Research Site

Mesquite, Texas, United States

Research Site

The Woodlands, Texas, United States

Research Site

Bothell, Washington, United States

Research Site

South Charleston, West Virginia, United States

Research Site

Ponce, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: BACKGROUND

PMID: 30915626 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20140339

Identifier Type: -

Identifier Source: org_study_id