Arthritis, Rheumatoid; Arthritis, Psoriatic Clinical Trial
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
| Verified date | July 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 111 |
| Est. completion date | October 9, 2017 |
| Est. primary completion date | September 8, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Research Site | Ponce | |
| United States | Research Site | Bay City | Michigan |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Bothell | Washington |
| United States | Research Site | Cutler Bay | Florida |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | Doral | Florida |
| United States | Research Site | El Cajon | California |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Flowood | Mississippi |
| United States | Research Site | Freehold | New Jersey |
| United States | Research Site | Grand Rapids | Michigan |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Largo | Florida |
| United States | Research Site | Lomita | California |
| United States | Research Site | Mesquite | Texas |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Middleburg Heights | Ohio |
| United States | Research Site | Orangeburg | South Carolina |
| United States | Research Site | Quincy | Illinois |
| United States | Research Site | Sherman Oaks | California |
| United States | Research Site | Skokie | Illinois |
| United States | Research Site | Smithtown | New York |
| United States | Research Site | South Charleston | West Virginia |
| United States | Research Site | The Woodlands | Texas |
| United States | Research Site | Thousand Oaks | California |
| United States | Research Site | Winter Haven | Florida |
| United States | Research Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Puerto Rico,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Injection Site Pain | 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. | Immediately following injection of each study drug on day 1 and day 8 of this crossover study | |
| Secondary | Injection Site Pain by Disease Indication | 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. | Immediately following injection of each study drug on day 1 and day 8 of this crossover study | |
| Secondary | Number of Participants With Adverse Events | The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | From first dose of etanercept to 30 days after the last dose; 38 days. |