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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02986139
• Date of registration: 02/11/2016
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis
• Scientific 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
• Date of first enrolment: November 29, 2016
• Target sample size: 111
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02986139
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid; Arthritis, Psoriatic

Intervention(s)

Drug: New Formulation Etanercept

Drug: Commercial Formulation Etanercept

Primary Outcome(s)

Injection Site Pain [Time Frame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study]

Secondary Outcome(s)

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]

Number of Participants With Adverse Events [Time Frame: From first dose of etanercept to 30 days after the last dose; 38 days.]

Secondary ID(s)

20140339

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02986139