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

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

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
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 |
Study Director: | MD | Amgen |
Documents provided by Amgen:
Publications:
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 |
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 |