Trial Outcomes & Findings for Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis (NCT NCT02986139)
NCT ID: NCT02986139
Last Updated: 2019-07-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Immediately following injection of each study drug on day 1 and day 8 of this crossover study
Results posted on
2019-07-18
Participant Flow
This study was conducted at 23 centers in the United States. The first participant enrolled on 29 November 2016 and the last participant enrolled on 01 September 2017.
Participants were randomized 1:1 to receive each etanercept formulation in 1 of 2 treatment sequences: AB (treatment A followed by treatment B) or BA (treatment B followed by treatment A).
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
|
Overall Study
Received Etanercept
|
56
|
53
|
|
Overall Study
COMPLETED
|
55
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Sponsor Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Sequence AB
n=56 Participants
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).
|
Sequence BA
n=55 Participants
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).
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Actual Indication
Rheumatoid Arthritis
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Actual Indication
Psoriatic Arthritis
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following injection of each study drug on day 1 and day 8 of this crossover studyPopulation: The primary analysis set included all participants who received both doses of commercial and new etanercept during each study period and who completed the injection site pain score during both study periods.
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.
Outcome measures
| Measure |
Etanercept Commercial Formulation
n=104 Participants
Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
|
Etanercept New Formulation
n=104 Participants
Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
|
Etanercept New Formulation - RA
Participants with RA received a single 50 mg SC dose of etanercept new formulation.
|
Etanercept New Formulation - PsA
Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept new formulation.
|
|---|---|---|---|---|
|
Injection Site Pain
|
23.6 mm
Standard Deviation 22.3
|
19.8 mm
Standard Deviation 22.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately following injection of each study drug on day 1 and day 8 of this crossover studyPopulation: Primary analysis set
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.
Outcome measures
| Measure |
Etanercept Commercial Formulation
n=81 Participants
Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
|
Etanercept New Formulation
n=23 Participants
Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
|
Etanercept New Formulation - RA
n=81 Participants
Participants with RA received a single 50 mg SC dose of etanercept new formulation.
|
Etanercept New Formulation - PsA
n=23 Participants
Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept new formulation.
|
|---|---|---|---|---|
|
Injection Site Pain by Disease Indication
|
23.7 mm
Standard Deviation 20.2
|
23.3 mm
Standard Deviation 29.0
|
20.5 mm
Standard Deviation 22.6
|
17.2 mm
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: From first dose of etanercept to 30 days after the last dose; 38 days.Population: The safety analysis set included all participants who received at least 1 dose of etanercept during the study.
The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Etanercept Commercial Formulation
n=106 Participants
Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
|
Etanercept New Formulation
n=107 Participants
Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
|
Etanercept New Formulation - RA
Participants with RA received a single 50 mg SC dose of etanercept new formulation.
|
Etanercept New Formulation - PsA
Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept new formulation.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
All adverse events
|
10 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of etanercept
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Etanercept Commercial Formulation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Etanercept New Formulation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept Commercial Formulation
n=106 participants at risk
Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
|
Etanercept New Formulation
n=107 participants at risk
Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
|
|---|---|---|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Etanercept Commercial Formulation
n=106 participants at risk
Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
|
Etanercept New Formulation
n=107 participants at risk
Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site erythema
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site papule
|
0.00%
0/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site reaction
|
1.9%
2/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site swelling
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site warmth
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Limb operation
|
0.94%
1/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/106 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.93%
1/107 • From first dose of etanercept to 30 days after the last dose; 38 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER