Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel (EGALITY)
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ClinicalTrials.gov Identifier: NCT01891864 |
Recruitment Status :
Completed
First Posted : July 3, 2013
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Chronic Stable Plaque Psoriasis |
Interventions |
Drug: GP2015 Etanercept Drug: Enbrel |
Enrollment | 531 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | GP2015 Etanercept | Enbrel ® Etanercept | GP2015 Etanercept Continued | Enbrel ® Etanercept Continued | GP2015 Etanercept Switched | Enbrel ® Etanercept Switched |
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Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter GP2015 Etanercept |
Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter Enbrel ® Etanercept |
GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2). GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2 |
Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2) Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
GP2015/Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2). Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
Enbrel ®/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2). GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
Period Title: Treatment Period 1 | ||||||
Started | 264 | 267 | 0 [1] | 0 [1] | 0 [1] | 0 [1] |
Completed | 256 [2] | 255 [3] | 0 | 0 | 0 | 0 |
Not Completed | 8 | 12 | 0 | 0 | 0 | 0 |
Reason Not Completed | ||||||
Protocol Violation / IMP non-compliance | 1 | 1 | 0 | 0 | 0 | 0 |
Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 |
Adverse Event, Serious, Fatal | 0 | 1 | 0 | 0 | 0 | 0 |
Adverse Event / Injection Site Reaction | 4 | 4 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 2 | 5 | 0 | 0 | 0 | 0 |
Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
[1]
Treatment arm applicable only in Treatment Period 2 and Extension Period
[2]
6 patients discontinued after completion of Treatment Period 1 and did NOT start Treatment Period 2
[3]
8 patients discontinued after completion of Treatment Period 1 and did NOT start Treatment Period 2
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Period Title: Treatment Period 2 | ||||||
Started | 0 [1] | 0 [1] | 150 [2] | 151 [3] | 100 [2] | 96 [3] |
Completed | 0 | 0 | 143 | 142 | 96 | 91 |
Not Completed | 0 | 0 | 7 | 9 | 4 | 5 |
Reason Not Completed | ||||||
Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 |
Site Termination | 0 | 0 | 1 | 2 | 0 | 0 |
Lack of Efficacy | 0 | 0 | 1 | 0 | 1 | 0 |
Adverse Event | 0 | 0 | 1 | 2 | 0 | 4 |
Termination of Site | 0 | 0 | 0 | 0 | 2 | 0 |
Withdrawal by Subject | 0 | 0 | 3 | 4 | 1 | 1 |
[1]
Treatment arm applicable for Treatment Period 1 only (patients re-randomized in Treatment Period 2)
[2]
Part of the patients re-randomized from "GP2015 Etanercept" treatment arm in Treatment Period 1
[3]
Part of the patients re-randomized from "Enbrel ® Etanercept" treatment arm in Treatment Period 1
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Period Title: Extension Period | ||||||
Started | 0 | 0 | 140 [1] | 142 | 95 [2] | 90 [3] |
Completed | 0 | 0 | 132 | 137 | 88 | 90 |
Not Completed | 0 | 0 | 8 | 5 | 7 | 0 |
Reason Not Completed | ||||||
Lack of Efficacy | 0 | 0 | 0 | 1 | 1 | 0 |
Pregnancy | 0 | 0 | 1 | 0 | 0 | 0 |
Adverse Event | 0 | 0 | 4 | 2 | 2 | 0 |
Withdrawal by Subject | 0 | 0 | 1 | 2 | 4 | 0 |
Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 0 |
[1]
2 patients withdrew consent 1 patient lost to FU between Treatment Period 2 and the Extension period
[2]
1 patient discontinued between Treatment Period 2 and Extension Period due to lack of efficacy
[3]
1 patient discontinued between Treatment Period 2 and Extension Period due to an adverse event
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Arm/Group Title | GP2015 Etanercept | Enbrel ® Etanercept | Total | |
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Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter GP2015 Etanercept |
Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter Enbrel ® Etanercept |
Total of all reporting groups | |
Overall Number of Baseline Participants | 264 | 267 | 531 | |
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All patients randomized in GP15-302 study
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 264 participants | 267 participants | 531 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
254 96.2%
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249 93.3%
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503 94.7%
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>=65 years |
10 3.8%
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18 6.7%
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28 5.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 264 participants | 267 participants | 531 participants | |
42.1 (12.29) | 42.7 (12.86) | 42.4 (12.57) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 264 participants | 267 participants | 531 participants | |
Female |
107 40.5%
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95 35.6%
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202 38.0%
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Male |
157 59.5%
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172 64.4%
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329 62.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 264 participants | 267 participants | 531 participants |
Czech Republic | 25 | 16 | 41 | |
Russian Federation | 9 | 8 | 17 | |
Romania | 9 | 24 | 33 | |
Hungary | 9 | 12 | 21 | |
Ukraine | 19 | 23 | 42 | |
Poland | 96 | 94 | 190 | |
South Africa | 4 | 1 | 5 | |
United Kingdom | 10 | 4 | 14 | |
Slovakia | 17 | 20 | 37 | |
Bulgaria | 13 | 8 | 21 | |
Germany | 12 | 17 | 29 | |
Estonia | 41 | 40 | 81 |
Name/Title: | Dr Guido Wuerth - Global Program Medical Director |
Organization: | Sandoz |
Phone: | +4980244762925 |
EMail: | guido.wuerth@sandoz.com |
Responsible Party: | Sandoz |
ClinicalTrials.gov Identifier: | NCT01891864 |
Other Study ID Numbers: |
GP15-302 |
First Submitted: | June 24, 2013 |
First Posted: | July 3, 2013 |
Results First Submitted: | September 26, 2016 |
Results First Posted: | March 27, 2017 |
Last Update Posted: | March 27, 2017 |