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

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ClinicalTrials.gov Identifier: NCT02986139
Recruitment Status : Completed
First Posted : December 8, 2016
Results First Posted : October 31, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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).

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid; Arthritis, Psoriatic Drug: Commercial Formulation Etanercept Drug: New Formulation Etanercept Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : September 8, 2017
Actual Study Completion Date : October 9, 2017


Arm Intervention/treatment
Experimental: 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).
Drug: 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.
Other Name: Enbrel

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.

Experimental: 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).
Drug: 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.
Other Name: Enbrel

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.




Primary Outcome Measures :
  1. Injection Site Pain [ Time Frame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study ]
    Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.


Secondary Outcome Measures :
  1. Injection Site Pain by Disease Indication [ Time Frame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study ]
    Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.

  2. Number of Participants With Adverse Events [ Time Frame: From first dose of etanercept to 30 days after the last dose; 38 days. ]
    The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986139


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35216
United States, California
Research Site
El Cajon, California, United States, 92020
Research Site
Lomita, California, United States, 90717
Research Site
Sherman Oaks, California, United States, 91403
Research Site
Thousand Oaks, California, United States, 91320
United States, Florida
Research Site
Cutler Bay, Florida, United States, 33157
Research Site
DeLand, Florida, United States, 32720
Research Site
Doral, Florida, United States, 33126
Research Site
Largo, Florida, United States, 33770
Research Site
Miami, Florida, United States, 33165
Research Site
Winter Haven, Florida, United States, 33880
United States, Illinois
Research Site
Quincy, Illinois, United States, 62301
Research Site
Skokie, Illinois, United States, 60076
United States, Michigan
Research Site
Bay City, Michigan, United States, 48706
Research Site
Grand Rapids, Michigan, United States, 49546
United States, Mississippi
Research Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64114
United States, New Jersey
Research Site
Freehold, New Jersey, United States, 07728
United States, New York
Research Site
Smithtown, New York, United States, 11787
United States, Ohio
Research Site
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Research Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Research Site
Orangeburg, South Carolina, United States, 29118
United States, Texas
Research Site
Dallas, Texas, United States, 75231
Research Site
El Paso, Texas, United States, 79935
Research Site
Houston, Texas, United States, 77034
Research Site
Mesquite, Texas, United States, 75150
Research Site
The Woodlands, Texas, United States, 77382
United States, Washington
Research Site
Bothell, Washington, United States, 98021
United States, West Virginia
Research Site
South Charleston, West Virginia, United States, 25309
Puerto Rico
Research Site
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] March 30, 2017
Statistical Analysis Plan  [PDF] May 31, 2017

Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02986139    
Other Study ID Numbers: 20140339
First Posted: December 8, 2016    Key Record Dates
Results First Posted: October 31, 2018
Last Update Posted: July 18, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors