Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    etanercept biosimilar sandoz
Previous Study | Return to List | Next Study

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel (EGALITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01891864
Recruitment Status : Completed
First Posted : July 3, 2013
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Study Type Interventional
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
Hide Arm/Group Description

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
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
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
Arm/Group Title GP2015 Etanercept Enbrel ® Etanercept Total
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
All patients randomized in GP15-302 study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 264 participants 267 participants 531 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
254
  96.2%
249
  93.3%
503
  94.7%
>=65 years
10
   3.8%
18
   6.7%
28
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 264 participants 267 participants 531 participants
Female
107
  40.5%
95
  35.6%
202
  38.0%
Male
157
  59.5%
172
  64.4%
329
  62.0%
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
1.Primary Outcome
Title PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
Hide Description The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of the primary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.
Arm/Group Title GP2015 Etanercept Enbrel ® Etanercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: % of patients achieving PASI75 response
73.4 75.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2015 Etanercept, Enbrel ® Etanercept
Comments PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval [−18%; 18%]. A logistic regression model was to be employed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-9.85 to 5.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in PASI Score up to Week 12
Hide Description The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.
Arm/Group Title GP2015 Etanercept Enbrel ® Etanercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 239 241
Least Squares Mean (Standard Error)
Unit of Measure: percentage difference
-56.11  (1.0578) -55.48  (1.0511)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2015 Etanercept, Enbrel ® Etanercept
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval [−15%; 15%].
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-3.474 to 2.204
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GP2015 Etanercept, Enbrel ® Etanercept
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval [−15%; 15%].
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-3.61 to 1.845
Estimation Comments [Not Specified]
3.Secondary Outcome
Title PASI 50, 75 and 90 Response Rates
Hide Description Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders .
Time Frame Week12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of this secondary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.
Arm/Group Title GP2015 Etanercept Enbrel ® Etanercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: percentage of patients
% of patients achieving PASI50 response at Week 12 99.2 97.9
% of patients achieving PASI75 response at Week 12 73.4 75.7
% of patients achieving PASI90 response at Week 12 39.2 34.1
4.Secondary Outcome
Title Injection Site Reactions
Hide Description Percentage of patients with injection site reactions up to Week 52
Time Frame Week52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on safety set including all patients who took at least 1 dose of study treatment
Arm/Group Title GP2015 Etanercept Continued Enbrel ® Etanercept Switched GP2015 Etanercept Switched Enbrel ® Etanercept Continued
Hide Arm/Group Description:

GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Overall Number of Participants Analyzed 164 96 100 171
Measure Type: Number
Unit of Measure: percentage of patients with ISRs
8.5 16.7 9.0 15.8
5.Secondary Outcome
Title Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
Hide Description Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on immunogenicity set consisting of patients who provided data for ADA assessment of etanercept at baseline visit.
Arm/Group Title GP2015 Etanercept Continued Enbrel ® Etanercept Switched GP2015 Etanercept Switched Enbrel ® Etanercept Continued
Hide Arm/Group Description:

GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Overall Number of Participants Analyzed 140 90 95 142
Measure Type: Number
Unit of Measure: percentage patients with positive ADA
0 1.1 0 3.5
Time Frame Adverse events are reported until the end of the study (week 52).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GP2015 Etanercept Continued Enbrel ® Etanercept Switched GP2015 Etanercept Switched Enbrel ® Etanercept Continued
Hide Arm/Group Description

GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).

GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).

Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.

All-Cause Mortality
GP2015 Etanercept Continued Enbrel ® Etanercept Switched GP2015 Etanercept Switched Enbrel ® Etanercept Continued
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GP2015 Etanercept Continued Enbrel ® Etanercept Switched GP2015 Etanercept Switched Enbrel ® Etanercept Continued
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/164 (4.27%)      6/96 (6.25%)      6/100 (6.00%)      7/171 (4.09%)    
Cardiac disorders         
Cardiopulmonary failure  1 [1]  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Eye disorders         
Retinal detachment  1  0/164 (0.00%)  0 1/96 (1.04%)  1 0/100 (0.00%)  0 0/171 (0.00%)  0
Gastrointestinal disorders         
Umbilical hernia  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Mesenteric vascular insufficiency  1  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
General disorders         
Fatigue  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Hepatobiliary disorders         
Drug-induced liver injury  1  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Cholelithiasis  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Immune system disorders         
Milk allergy  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Infections and infestations         
Appendicitis  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Pneumonia  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Brain abscess  1  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Lobar pneumonia  1  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Sepsis  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Diverticulitis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 0/100 (0.00%)  0 0/171 (0.00%)  0
Tonsillitis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 0/100 (0.00%)  0 0/171 (0.00%)  0
Eczema infected  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Injury, poisoning and procedural complications         
Meniscus injury  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Upper limb fracture  1  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Lower limb fracture  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Metabolism and nutrition disorders         
Acid-base balance disorder mixed  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Psoriatic arthropathy  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant melanoma in situ  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Squamous cell carcinoma of the cervix  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Nervous system disorders         
Cerebral infarction  1  0/164 (0.00%)  0 1/96 (1.04%)  1 0/100 (0.00%)  0 0/171 (0.00%)  0
Multiple sclerosis  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Renal and urinary disorders         
Renal failure acute  1  1/164 (0.61%)  1 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Respiratory failure  1  1/164 (0.61%)  1 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Epistaxis  1  0/164 (0.00%)  0 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Pulmonary sarcoidosis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 0/100 (0.00%)  0 0/171 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 0/171 (0.00%)  0
Skin and subcutaneous tissue disorders         
Psoriasis  1  0/164 (0.00%)  0 0/96 (0.00%)  0 1/100 (1.00%)  1 0/171 (0.00%)  0
Vascular disorders         
Thrombophlebitis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 0/100 (0.00%)  0 0/171 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
[1]
Fatal event
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
GP2015 Etanercept Continued Enbrel ® Etanercept Switched GP2015 Etanercept Switched Enbrel ® Etanercept Continued
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/164 (59.15%)      57/96 (59.38%)      60/100 (60.00%)      94/171 (54.97%)    
Blood and lymphatic system disorders         
Lymphadenopathy  1  4/164 (2.44%)  4 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Lymph node pain  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Eye disorders         
Eye haemorrhage  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  4/164 (2.44%)  4 3/96 (3.13%)  3 1/100 (1.00%)  1 2/171 (1.17%)  2
Abdominal pain upper  1  3/164 (1.83%)  3 0/96 (0.00%)  0 0/100 (0.00%)  0 3/171 (1.75%)  3
Nausea  1  0/164 (0.00%)  0 2/96 (2.08%)  2 1/100 (1.00%)  1 0/171 (0.00%)  0
Toothache  1  0/164 (0.00%)  0 3/96 (3.13%)  3 0/100 (0.00%)  0 0/171 (0.00%)  0
Gastritis  1  0/164 (0.00%)  0 2/96 (2.08%)  2 2/100 (2.00%)  2 4/171 (2.34%)  4
Dental caries  1  0/164 (0.00%)  0 2/96 (2.08%)  3 0/100 (0.00%)  0 0/171 (0.00%)  0
General disorders         
Pyrexia  1  0/164 (0.00%)  0 2/96 (2.08%)  2 2/100 (2.00%)  2 0/171 (0.00%)  0
Fatigue  1  1/164 (0.61%)  1 0/96 (0.00%)  0 0/100 (0.00%)  0 3/171 (1.75%)  3
Hepatobiliary disorders         
Hepatitis alcoholic  1  0/164 (0.00%)  0 2/96 (2.08%)  2 0/100 (0.00%)  0 0/171 (0.00%)  0
Hepatic steatosis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  20/164 (12.20%)  26 10/96 (10.42%)  15 14/100 (14.00%)  16 17/171 (9.94%)  22
Pharyngitis  1  7/164 (4.27%)  9 3/96 (3.13%)  4 5/100 (5.00%)  5 10/171 (5.85%)  11
Viral upper respiratory tract infection  1  5/164 (3.05%)  6 8/96 (8.33%)  12 4/100 (4.00%)  6 6/171 (3.51%)  7
Respiratory tract infection viral  1  4/164 (2.44%)  6 1/96 (1.04%)  1 4/100 (4.00%)  4 2/171 (1.17%)  4
Upper respiratory tract infection  1  4/164 (2.44%)  4 3/96 (3.13%)  3 1/100 (1.00%)  2 5/171 (2.92%)  9
Bronchitis  1  4/164 (2.44%)  4 0/96 (0.00%)  0 0/100 (0.00%)  0 3/171 (1.75%)  4
Rhinitis  1  2/164 (1.22%)  2 3/96 (3.13%)  4 1/100 (1.00%)  1 4/171 (2.34%)  5
Tonsillitis  1  5/164 (3.05%)  6 1/96 (1.04%)  1 1/100 (1.00%)  1 1/171 (0.58%)  1
Influenza  1  2/164 (1.22%)  2 0/96 (0.00%)  0 0/100 (0.00%)  0 3/171 (1.75%)  3
Oral herpes  1  0/164 (0.00%)  0 1/96 (1.04%)  1 2/100 (2.00%)  3 0/171 (0.00%)  0
Viral infection  1  3/164 (1.83%)  3 1/96 (1.04%)  1 1/100 (1.00%)  1 2/171 (1.17%)  2
Urinary tract infection  1  2/164 (1.22%)  2 1/96 (1.04%)  1 2/100 (2.00%)  2 3/171 (1.75%)  3
Cystitis  1  3/164 (1.83%)  3 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  1
Conjunctivitis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Folliculitis  1  0/164 (0.00%)  0 0/96 (0.00%)  0 2/100 (2.00%)  2 0/171 (0.00%)  0
Herpes simplex  1  0/164 (0.00%)  0 0/96 (0.00%)  0 2/100 (2.00%)  2 0/171 (0.00%)  0
Sinusitis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  2 0/171 (0.00%)  0
Upper respiratory tract infection bacterial  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Pyelonephritis  1  0/164 (0.00%)  0 0/96 (0.00%)  0 2/100 (2.00%)  2 0/171 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  6/164 (3.66%)  6 2/96 (2.08%)  2 1/100 (1.00%)  1 2/171 (1.17%)  2
Blood pressure increased  1  2/164 (1.22%)  2 0/96 (0.00%)  0 4/100 (4.00%)  4 2/171 (1.17%)  2
Gamma-glutamyltransferase increased  1  6/164 (3.66%)  6 0/96 (0.00%)  0 3/100 (3.00%)  3 0/171 (0.00%)  0
Weight increased  1  2/164 (1.22%)  2 0/96 (0.00%)  0 3/100 (3.00%)  3 4/171 (2.34%)  4
Aspartate aminotransferase increased  1  5/164 (3.05%)  5 2/96 (2.08%)  2 1/100 (1.00%)  1 1/171 (0.58%)  1
Blood uric acid increased  1  3/164 (1.83%)  3 0/96 (0.00%)  0 0/100 (0.00%)  0 2/171 (1.17%)  2
Metabolism and nutrition disorders         
Diabetes mellitus  1  0/164 (0.00%)  0 2/96 (2.08%)  2 1/100 (1.00%)  1 0/171 (0.00%)  0
Hyperuricaemia  1  0/164 (0.00%)  0 0/96 (0.00%)  0 2/100 (2.00%)  2 0/171 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Spinal pain  1  2/164 (1.22%)  2 0/96 (0.00%)  0 0/100 (0.00%)  0 2/171 (1.17%)  2
Back pain  1  7/164 (4.27%)  8 4/96 (4.17%)  5 2/100 (2.00%)  2 3/171 (1.75%)  3
Arthralgia  1  5/164 (3.05%)  6 5/96 (5.21%)  9 3/100 (3.00%)  4 7/171 (4.09%)  8
Pain in extremity  1  0/164 (0.00%)  0 1/96 (1.04%)  1 2/100 (2.00%)  2 0/171 (0.00%)  0
Myalgia  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Musculoskeletal pain  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Osteoarthritis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Nervous system disorders         
Headache  1  3/164 (1.83%)  3 3/96 (3.13%)  7 4/100 (4.00%)  5 8/171 (4.68%)  8
Somnolence  1  0/164 (0.00%)  0 0/96 (0.00%)  0 2/100 (2.00%)  2 0/171 (0.00%)  0
Schiatica  1  0/164 (0.00%)  0 2/96 (2.08%)  2 0/100 (0.00%)  0 0/171 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  3/164 (1.83%)  3 1/96 (1.04%)  1 1/100 (1.00%)  1 1/171 (0.58%)  1
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/164 (1.83%)  3 0/96 (0.00%)  0 3/100 (3.00%)  3 2/171 (1.17%)  2
Oropharyngeal pain  1  3/164 (1.83%)  3 1/96 (1.04%)  1 3/100 (3.00%)  3 2/171 (1.17%)  3
Skin and subcutaneous tissue disorders         
Psoriasis  1  0/164 (0.00%)  0 1/96 (1.04%)  1 2/100 (2.00%)  3 5/171 (2.92%)  5
Pruritus  1  2/164 (1.22%)  2 0/96 (0.00%)  0 0/100 (0.00%)  0 4/171 (2.34%)  4
Dermatitis psoriasiform  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Dermatitis allergic  1  3/164 (1.83%)  3 0/96 (0.00%)  0 0/100 (0.00%)  0 1/171 (0.58%)  2
Pruritus generalized  1  0/164 (0.00%)  0 1/96 (1.04%)  1 1/100 (1.00%)  1 0/171 (0.00%)  0
Vascular disorders         
Hypertenson  1  5/164 (3.05%)  5 2/96 (2.08%)  2 3/100 (3.00%)  3 7/171 (4.09%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At least sixty days prior to submitting/presenting manuscript or other materials relating to the study a copy should be provided to Sandoz and Sandoz has sixty days to review and comment. Sandoz has the right to require amendments to any such proposed presentation or publication on reasonable grounds. Sandoz may require any proposed publication or presentation to be delayed for up to four months to enable a patent application to be prepared and filed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Guido Wuerth - Global Program Medical Director
Organization: Sandoz
Phone: +4980244762925
EMail: guido.wuerth@sandoz.com
Layout table for additonal information
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01891864     History of Changes
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