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Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis (EQUIRA)

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ClinicalTrials.gov Identifier: NCT02638259
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : February 23, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: GP2015
Enrollment 376
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Period Title: Treatment Period 1
Started 186 190
Completed 181 172
Not Completed 5 18
Reason Not Completed
Adverse Event             1             5
Death             0             1
Lack of Efficacy             0             1
Protocol Violation             0             3
Withdrawal by Subject             4             6
Withdrawn per sponsor decision             0             2
Period Title: Treatment Period 2
Started 175 [1] 166 [2]
Completed 169 155
Not Completed 6 11
Reason Not Completed
Adverse Event             5             4
Withdrawal by Subject             1             7
[1]
6 patients did not proceed to TP2 (3 not eligible, 2 consent withdrawal, 1 IP delay)
[2]
6 patients did not proceed to TP2 (4 not eligible, 1 consent withdrawal, 1 adverse event).
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel Total
Hide Arm/Group Description Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator Total of all reporting groups
Overall Number of Baseline Participants 186 190 376
Hide Baseline Analysis Population Description
Baseline characteristics are presented for Full Analysis Set (FAS). The FAS is comprised of all randomized patients to whom study treatment has been assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 186 participants 190 participants 376 participants
55.2  (11.22) 53.1  (12.70) 54.1  (12.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 190 participants 376 participants
Female
158
  84.9%
150
  78.9%
308
  81.9%
Male
28
  15.1%
40
  21.1%
68
  18.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 190 participants 376 participants
American Indian or Alaska Native
1
   0.5%
1
   0.5%
2
   0.5%
Asian
0
   0.0%
3
   1.6%
3
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   2.7%
1
   0.5%
6
   1.6%
White
180
  96.8%
185
  97.4%
365
  97.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 190 participants 376 participants
Hungary
7
   3.8%
12
   6.3%
19
   5.1%
United States
23
  12.4%
26
  13.7%
49
  13.0%
Czechia
16
   8.6%
15
   7.9%
31
   8.2%
United Kingdom
3
   1.6%
4
   2.1%
7
   1.9%
Spain
5
   2.7%
5
   2.6%
10
   2.7%
Russia
12
   6.5%
10
   5.3%
22
   5.9%
Latvia
6
   3.2%
2
   1.1%
8
   2.1%
Poland
44
  23.7%
48
  25.3%
92
  24.5%
Italy
1
   0.5%
0
   0.0%
1
   0.3%
Mexico
4
   2.2%
5
   2.6%
9
   2.4%
Slovakia
3
   1.6%
5
   2.6%
8
   2.1%
Bulgaria
11
   5.9%
11
   5.8%
22
   5.9%
Lithuania
9
   4.8%
12
   6.3%
21
   5.6%
Serbia
12
   6.5%
10
   5.3%
22
   5.9%
Germany
4
   2.2%
5
   2.6%
9
   2.4%
Estonia
26
  14.0%
20
  10.5%
46
  12.2%
1.Primary Outcome
Title Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel
Hide Description Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value >5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value < 2.6 corresponds to remission DAS28-CRP = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GDA + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm
Time Frame treatment period 1: up to 24 weeks
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Hide Analysis Population Description
Treatment Period 1 Per-Protocol set
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-2.80  (0.113) -2.73  (0.117)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg GP2015, 50mg EU-authorized Enbrel
Comments Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval [-0.6; 0.6]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.
Type of Statistical Test Equivalence
Comments A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.26 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.097
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel
Hide Description Frequency of participants with injection site reactions in GP2015 and Enbrel
Time Frame Treatment Period 1, up to 24 weeks
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Hide Analysis Population Description
Safety Set
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 186 190
Measure Type: Count of Participants
Unit of Measure: Participants
All injection site reactions
13
   7.0%
35
  18.4%
Moderate injection site reactions
1
   0.5%
5
   2.6%
Severe injection site reactions
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients
Hide Description Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate
Time Frame baseline, week 2, week 4, week 12, week 24
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Safety Set
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 186 190
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
2
   1.1%
0
   0.0%
Week 2
2
   1.1%
5
   2.6%
Week 4
3
   1.6%
42
  22.1%
Week 12
0
   0.0%
5
   2.6%
Week 24
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;
Hide Description

DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score.

DAS28-CRP and DAS28-ESR:

  1. best is 0,
  2. < 2.6 – remission,
  3. ≥ 2.6 to ≤ 3.2 – low disease activity
  4. > 3.2 to ≤ 5.1 – moderate disease activity
  5. > 5.1 – high disease activity

DAS28-ESR = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm

Time Frame week 4, 12, 24
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Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: score on a scale
DAS28-CRP baseline Number Analyzed 168 participants 155 participants
5.42  (0.921) 5.53  (0.783)
DAS28-CRP week 4 Number Analyzed 165 participants 153 participants
3.81  (1.079) 3.82  (1.077)
DAS28-CRP week 12 Number Analyzed 165 participants 150 participants
3.15  (1.045) 3.31  (1.088)
DAS28-CRP week 24 Number Analyzed 168 participants 155 participants
2.63  (0.910) 2.75  (0.928)
DAS28-ESR baseline Number Analyzed 168 participants 155 participants
6.34  (0.882) 6.41  (0.768)
DAS28-ESR week 4 Number Analyzed 167 participants 154 participants
4.62  (1.183) 4.56  (1.204)
DAS28-ESR week 12 Number Analyzed 168 participants 154 participants
3.84  (1.216) 3.94  (1.284)
DAS28-ESR week 24 Number Analyzed 168 participants 155 participants
3.24  (1.060) 3.32  (1.099)
5.Secondary Outcome
Title Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24
Hide Description [Not Specified]
Time Frame baseline, Week 4, week 12, week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: score on a scale
DAS28-CRP change from baseline week 4 Number Analyzed 165 participants 153 participants
-1.59  (1.032) -1.70  (1.001)
DAS28-CRP change from baseline week 12 Number Analyzed 165 participants 150 participants
-2.23  (1.030) -2.20  (1.071)
DAS28-CRP change from baseline week 24 Number Analyzed 168 participants 155 participants
-2.78  (1.058) -2.78  (1.028)
DAS28-ESR change from baseline week 4 Number Analyzed 167 participants 154 participants
-1.72  (1.068) -1.85  (1.078)
DAS28-ESR change from baseline week 12 Number Analyzed 168 participants 154 participants
-2.50  (1.145) -2.47  (1.218)
DAS28-ESR change from baseline week 24 Number Analyzed 168 participants 155 participants
-3.10  (1.157) -3.09  (1.119)
6.Secondary Outcome
Title Treatment Period 1- Proportion of Patients Achieving EULAR Response
Hide Description Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline > 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement > 0.6 and ≤ 1.2, or DAS28 > 3.2 and ≤ 5.1 and DAS28 improvement > 0.6 or DAS28 > 5.1 but DAS28 improvement > 1.2) ;
Time Frame week 4, week 12 and week 24
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Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
Good response week 4 Number Analyzed 167 participants 154 participants
26
  15.6%
21
  13.6%
Good response week 12 Number Analyzed 168 participants 154 participants
54
  32.1%
47
  30.5%
Good response week 24 Number Analyzed 168 participants 155 participants
88
  52.4%
74
  47.7%
Moderate response week 4 Number Analyzed 167 participants 154 participants
95
  56.9%
99
  64.3%
Moderate response week 12 Number Analyzed 168 participants 154 participants
103
  61.3%
91
  59.1%
Moderate response week 24 Number Analyzed 168 participants 155 participants
76
  45.2%
77
  49.7%
no response week 4 Number Analyzed 167 participants 154 participants
46
  27.5%
34
  22.1%
no response week 12 Number Analyzed 168 participants 154 participants
11
   6.5%
16
  10.4%
no response week 24 Number Analyzed 168 participants 155 participants
4
   2.4%
4
   2.6%
7.Secondary Outcome
Title Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24
Hide Description % patients in DAS28-ESR categories up to week 24
Time Frame week 4, week 12 and week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 - remission (DAS28 <2.6)
9
   5.4%
7
   4.5%
Week 12 - remission (DAS28 <2.6)
21
  12.5%
21
  13.5%
Week 24 - remission (DAS28 <2.6)
46
  27.4%
41
  26.5%
8.Secondary Outcome
Title Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
Hide Description Proportion of patients achieving EULAR/American College of Rheumatology (EULAR/ACR) Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1–10) ≤ 1) at Weeks 4, 12 and 24;
Time Frame week 4, week 12, week 24
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Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
week 4 Number Analyzed 165 participants 153 participants
1
   0.6%
2
   1.3%
week 12 Number Analyzed 165 participants 150 participants
9
   5.5%
8
   5.3%
week 24 Number Analyzed 168 participants 155 participants
24
  14.3%
15
   9.7%
9.Secondary Outcome
Title Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24;
Hide Description

ACR20 response was defined if a patient fulfilled all 3 criteria below:

  • 20% improvement in tender 68 joint-count
  • 20% improvement in swollen 68 joint-count;

And 20% improvement in at least 3 of the following 5 measures:

  • Patient’s assessment of RA pain (visual analogue scale (VAS) 100 mm),
  • Patient’s global assessment of disease activity (VAS 100 mm),
  • Physician’s global assessment of disease activity (VAS 100 mm),
  • Patient self-assessed disability (HAQ score),
  • Acute phase reactant (CRP or ESR). ACR50 and ACR70 responses were defined as ACR20 response replacing “20% improvement” by “50% improvement” and “70% improvement”, respectively.
Time Frame Week 4, week 12 and week 24
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Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
ACR20 response Week 4 Number Analyzed 166 participants 154 participants
80
  48.2%
83
  53.9%
ACR20 response Week 12 Number Analyzed 166 participants 154 participants
131
  78.9%
116
  75.3%
ACR20 response Week 24 Number Analyzed 167 participants 155 participants
147
  88.0%
144
  92.9%
ACR50 response Week 4 Number Analyzed 166 participants 154 participants
25
  15.1%
28
  18.2%
ACR50 response Week 12 Number Analyzed 166 participants 154 participants
55
  33.1%
68
  44.2%
ACR50 response Week 24 Number Analyzed 167 participants 155 participants
107
  64.1%
110
  71.0%
ACR70 response Week 4 Number Analyzed 166 participants 154 participants
8
   4.8%
7
   4.5%
ACR70 response Week 12 Number Analyzed 166 participants 154 participants
21
  12.7%
26
  16.9%
ACR70 response Week 24 Number Analyzed 167 participants 155 participants
56
  33.5%
66
  42.6%
10.Secondary Outcome
Title Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;
Hide Description

ACR-N (American College of Rheumatology percentage of improvement): negative is worsening, positive (up to 100) is an improvement.

ACR-N is a single number that characterizes the percentage of improvement from Baseline that a patient has experienced in analogy to ACR20 described above. ACR-N of X (such as 38) means that the patient had achieved an improvement of at least X% (such as 38%) in tender and swollen joints, and an improvement of at least X% (such as 38%) in 3 of the 5 other parameters mentioned above.

Time Frame Weeks 4, 12 and 24;
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Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: score on a scale
week 4 Number Analyzed 166 participants 154 participants
19.9  (29.89) 22.6  (34.02)
week 12 Number Analyzed 166 participants 154 participants
38.3  (27.46) 38.7  (35.32)
week 24 Number Analyzed 167 participants 155 participants
55.4  (27.61) 59.4  (25.40)
11.Secondary Outcome
Title Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI
Hide Description Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI > 26, moderate disease activity, SDAI > 11 to ≤ 26, low disease activity, SDAI > 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient’s and physician’s global assessment of disease activity.
Time Frame Weeks 4, 12 and 24;
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline : Remission (SDAI<=3.3)
0
   0.0%
0
   0.0%
Baseline: Low (3.3 < SDAI <= 11)
0
   0.0%
0
   0.0%
Baseline : Moderate (11 < SDAI <= 26
26
  15.5%
19
  12.3%
Baseline : High (SDAI > 26)
142
  84.5%
136
  87.7%
Week 4:Remission (SDAI<=3.3)
5
   3.0%
4
   2.6%
Week 4:Low (3.3 < SDAI <= 11)
35
  20.8%
31
  20.0%
Week 4: Moderate (11 < SDAI <= 26
84
  50.0%
82
  52.9%
Week 4:High (SDAI > 26)
41
  24.4%
36
  23.2%
Week 12:Remission (SDAI<=3.3)
15
   8.9%
13
   8.4%
Week 12:Low (3.3 < SDAI <= 11)
61
  36.3%
58
  37.4%
Week 12: Moderate (11 < SDAI <= 26
75
  44.6%
68
  43.9%
Week 12:High (SDAI > 26)
14
   8.3%
11
   7.1%
Week 24: Remission (SDAI<=3.3)
38
  22.6%
31
  20.0%
Week 24: Low (3.3 < SDAI <= 11)
83
  49.4%
81
  52.3%
Week 24 : Moderate (11 < SDAI <= 26
45
  26.8%
38
  24.5%
Week 24 :High (SDAI > 26)
2
   1.2%
5
   3.2%
12.Secondary Outcome
Title Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI
Hide Description Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI > 22, moderate disease activity, CDAI > 10 to ≤ 22, low disease activity, CDAI > 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient’s and physician’s global assessment of disease activity.
Time Frame Weeks 4, 12 and 24;
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline : Remission (CDAI<=2.8)
0
   0.0%
0
   0.0%
Baseline: Low (2.8 < CDAI <= 10)
0
   0.0%
0
   0.0%
Baseline : Moderate (10 < CDAI <= 22
17
  10.1%
7
   4.5%
Baseline : High (CDAI > 22)
151
  89.9%
148
  95.5%
Week 4:Remission(CDAI<=2.8)
4
   2.4%
3
   1.9%
Week 4: Low (2.8 < CDAI <= 10)
33
  19.6%
31
  20.0%
Week 4: Moderate (10 < CDAI <= 22)
67
  39.9%
71
  45.8%
Week 4:High High (CDAI > 22)
63
  37.5%
49
  31.6%
Week 12:Remission(CDAI<=2.8)
14
   8.3%
15
   9.7%
Week 12: Low (2.8 < CDAI <= 10)
63
  37.5%
53
  34.2%
Week 12: Moderate (10 < CDAI <= 22)
72
  42.9%
63
  40.6%
Week 12:High (CDAI > 22)
19
  11.3%
23
  14.8%
Week 24: Remission (CDAI<=2.8)
35
  20.8%
31
  20.0%
Week 24: Low (2.8 < CDAI <= 10)
81
  48.2%
78
  50.3%
Week 24 : (10 < CDAI <= 22)
46
  27.4%
39
  25.2%
Week 24 :High (CDAI > 22)
6
   3.6%
7
   4.5%
13.Secondary Outcome
Title Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Hide Description Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)
Time Frame Weeks 4, 12 and 24;
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 168 participants 154 participants
11
   6.5%
5
   3.2%
Week 4 Number Analyzed 167 participants 153 participants
22
  13.2%
30
  19.6%
Week 12 Number Analyzed 168 participants 154 participants
40
  23.8%
46
  29.9%
Week 24 Number Analyzed 166 participants 152 participants
54
  32.5%
62
  40.8%
14.Secondary Outcome
Title Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;
Hide Description Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)
Time Frame Baseline, Weeks 4, 12 and 24;
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 168 participants 155 participants
1.44  (0.547) 1.47  (0.561)
Week 4 Number Analyzed 167 participants 153 participants
1.19  (0.558) 1.14  (0.611)
Week 12 Number Analyzed 168 participants 154 participants
1.02  (0.560) 0.97  (0.599)
Week 24 Number Analyzed 166 participants 152 participants
0.88  (0.601) 0.80  (0.589)
15.Secondary Outcome
Title Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;
Hide Description FACIT fatigue scale is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function, ranging from 0 (worst) to 52 (best). A score of less than 30 indicates severe fatigue.
Time Frame Baseline, Weeks 4, 12 and 24;
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 156 participants 146 participants
27.0  (9.67) 25.1  (10.33)
Week 4 Number Analyzed 167 participants 154 participants
31.6  (8.83) 30.9  (10.01)
Week 12 Number Analyzed 168 participants 154 participants
34.4  (8.93) 33.9  (9.6)
Week 24 Number Analyzed 168 participants 155 participants
36.3  (8.94) 36.7  (9.24)
16.Secondary Outcome
Title Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24
Hide Description [Not Specified]
Time Frame Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 168 participants 155 participants
1.19  (2.194) 1.10  (1.526)
Week 4 Number Analyzed 165 participants 153 participants
0.36  (0.718) 0.43  (0.693)
Week 12 Number Analyzed 165 participants 150 participants
0.33  (0.772) 0.48  (0.850)
Week 24 Number Analyzed 168 participants 155 participants
0.44  (0.949) 0.35  (0.466)
17.Secondary Outcome
Title Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24
Hide Description [Not Specified]
Time Frame Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 168 155
Mean (Standard Deviation)
Unit of Measure: mm/h
Baseline Number Analyzed 168 participants 155 participants
41.4  (16.89) 41.8  (17.94)
Week 4 Number Analyzed 167 participants 154 participants
26.5  (16.51) 26.7  (17.27)
Week 12 Number Analyzed 168 participants 154 participants
23.2  (14.67) 23.8  (15.41)
Week 24 Number Analyzed 168 participants 155 participants
21.4  (15.47) 20.8  (14.05)
18.Secondary Outcome
Title Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;
Hide Description

DAS28-CRP and DAS28-ESR:

  1. best is 0,
  2. < 2.6 – remission,
  3. ≥ 2.6 to ≤ 3.2 – low disease activity
  4. > 3.2 to ≤ 5.1 – moderate disease activity
  5. > 5.1 – high disease activity
Time Frame Baseline, week 4, week 12, week 24, week 36 and week 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: score on a scale
DAS28-CRP Baseline Number Analyzed 148 participants 131 participants
5.45  (0.914) 5.57  (0.794)
DAS28-CRP Week 4 Number Analyzed 145 participants 129 participants
3.89  (1.053) 3.79  (1.101)
DAS28-CRP Week 12 Number Analyzed 146 participants 127 participants
3.20  (1.038) 3.27  (1.127)
DAS28-CRP Week 24 Number Analyzed 148 participants 131 participants
2.64  (0.863) 2.67  (0.892)
DAS28-CRP Week 36 Number Analyzed 147 participants 130 participants
2.65  (1.001) 2.74  (1.017)
DAS28-CRP Week 48 Number Analyzed 148 participants 131 participants
2.57  (1.067) 2.74  (1.062)
DAS28-ESR Baseline Number Analyzed 148 participants 131 participants
6.39  (0.872) 6.43  (0.784)
DAS28-ESR Week 4 Number Analyzed 147 participants 130 participants
4.70  (1.175) 4.49  (1.228)
DAS28-ESR Week 12 Number Analyzed 148 participants 130 participants
3.90  (1.236) 3.85  (1.317)
DAS28-ESR Week 24 Number Analyzed 148 participants 131 participants
3.23  (1.022) 3.19  (1.048)
DAS28-ESR Week 36 Number Analyzed 147 participants 131 participants
3.25  (1.160) 3.28  (1.127)
DAS28-ESR Week 48 Number Analyzed 147 participants 129 participants
3.20  (1.201) 3.30  (1.177)
19.Secondary Outcome
Title Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48
Hide Description [Not Specified]
Time Frame week 4, week 12, week 24, week 36, week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: score on a scale
DAS28-CRP change from baseline, week 4 Number Analyzed 145 participants 129 participants
-1.55  (1.014) -1.76  (1.014)
DAS28-CRP change from baseline, week 12 Number Analyzed 146 participants 127 participants
-2.22  (1.031) -2.27  (1.096)
DAS28-CRP change from baseline, week 24 Number Analyzed 148 participants 131 participants
-2.81  (1.007) -2.90  (0.988)
DAS28-CRP change from baseline, week 36 Number Analyzed 147 participants 130 participants
-2.80  (1.087) -2.82  (1.151)
DAS28-CRP change from baseline, week 48 Number Analyzed 148 participants 131 participants
-2.88  (1.198) -2.83  (1.176)
DAS28-ESR change from baseline, week 4 Number Analyzed 147 participants 130 participants
-1.69  (1.048) -1.92  (1.087)
DAS28-ESR change from baseline, week 12 Number Analyzed 148 participants 130 participants
-2.49  (1.152) -2.57  (1.235)
DAS28-ESR change from baseline, week 24 Number Analyzed 148 participants 131 participants
-3.16  (1.106) -3.23  (1.054)
DAS28-ESR change from baseline, week 36 Number Analyzed 147 participants 131 participants
-3.13  (1.232) -3.14  (1.154)
DAS28-ESR change from baseline, week 48 Number Analyzed 147 participants 129 participants
-3.20  (1.297) -3.14  (1.190)
20.Secondary Outcome
Title Treatment Period 2: Proportion of Patients Achieving EULAR Reponse
Hide Description Proportion of patients achieving EULAR good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline > 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement > 0.6 and ≤ 1.2, or DAS28 > 3.2 and ≤ 5.1 and DAS28 improvement > 0.6 or DAS28 > 5.1 but DAS28 improvement > 1.2) at Weeks 36 and 48;
Time Frame week 4, week 12, week 24, week 36 and week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
Good response week 4 Number Analyzed 147 participants 130 participants
20
  13.6%
20
  15.4%
Good response week 12 Number Analyzed 148 participants 130 participants
43
  29.1%
43
  33.1%
Good response week 24 Number Analyzed 148 participants 131 participants
77
  52.0%
68
  51.9%
Good response week 36 Number Analyzed 147 participants 131 participants
82
  55.8%
65
  49.6%
Good response week 48 Number Analyzed 147 participants 129 participants
80
  54.4%
67
  51.9%
Moderate response week 4 Number Analyzed 147 participants 130 participants
85
  57.8%
82
  63.1%
Moderate response week 12 Number Analyzed 148 participants 130 participants
95
  64.2%
75
  57.7%
Moderate response week 24 Number Analyzed 148 participants 131 participants
71
  48.0%
63
  48.1%
Moderate response week 36 Number Analyzed 147 participants 131 participants
62
  42.2%
64
  48.9%
Moderate response week 48 Number Analyzed 147 participants 129 participants
61
  41.5%
57
  44.2%
no response week 4 Number Analyzed 148 participants 130 participants
42
  28.4%
28
  21.5%
no response week 12 Number Analyzed 148 participants 130 participants
10
   6.8%
12
   9.2%
no response week 24 Number Analyzed 148 participants 131 participants
0
   0.0%
0
   0.0%
no response week 36 Number Analyzed 147 participants 131 participants
3
   2.0%
2
   1.5%
no response week 48 Number Analyzed 147 participants 129 participants
6
   4.1%
5
   3.9%
21.Secondary Outcome
Title Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;
Hide Description percentage of participants in DAS28-ESR categories up to week 48
Time Frame week 36 and week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
Week 36 Remission (DAS28 < 2.6)
45
  30.4%
38
  29.0%
Week 48 Remission (DAS28 < 2.6)
44
  29.7%
35
  26.7%
22.Secondary Outcome
Title Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
Hide Description Proportion of patients achieving EULAR/ACR Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1–10) ≤ 1) at Weeks 36 and 48;
Time Frame week 4, week 12, week 24, week 36, week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 145 participants 129 participants
0
   0.0%
2
   1.6%
Week 12 Number Analyzed 146 participants 127 participants
9
   6.2%
8
   6.3%
Week 24 Number Analyzed 148 participants 131 participants
22
  14.9%
13
   9.9%
Week 36 Number Analyzed 147 participants 130 participants
25
  17.0%
15
  11.5%
Week 48 Number Analyzed 148 participants 131 participants
28
  18.9%
20
  15.3%
23.Secondary Outcome
Title Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;
Hide Description [Not Specified]
Time Frame week 36 and week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
ACR20 response Week 36 Number Analyzed 146 participants 131 participants
128
  87.7%
114
  87.0%
ACR20 response Week 48 Number Analyzed 147 participants 131 participants
131
  89.1%
108
  82.4%
ACR50 response Week 36 Number Analyzed 146 participants 131 participants
90
  61.6%
83
  63.4%
ACR50 response Week 48 Number Analyzed 147 participants 131 participants
93
  63.3%
86
  65.6%
ACR70 response Week 36 Number Analyzed 146 participants 131 participants
47
  32.2%
50
  38.2%
ACR70 response Week 48 Number Analyzed 147 participants 131 participants
54
  36.7%
55
  42.0%
24.Secondary Outcome
Title Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;
Hide Description ACR-N: negative is worsening, positive (up to 100) is an improvement
Time Frame week 36 and week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 Number Analyzed 146 participants 130 participants
19.7  (27.72) 24.9  (29.40)
Week 12 Number Analyzed 146 participants 130 participants
38.3  (27.84) 40.7  (34.80)
Week 24 Number Analyzed 147 participants 131 participants
56.3  (26.58) 60.9  (24.79)
Week 36 Number Analyzed 146 participants 131 participants
53.8  (28.21) 55.7  (28.37)
Week 48 Number Analyzed 147 participants 131 participants
56.9  (29.18) 56.4  (30.58)
25.Secondary Outcome
Title Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI
Hide Description Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI > 26, moderate disease activity, SDAI > 11 to ≤ 26, low disease activity, SDAI > 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 36 and 48.
Time Frame baseline, week 4, week 12, week 24, week 36. week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline : Remission (SDAI <= 3.3)
0
   0.0%
0
   0.0%
Baseline : Low (3.3 < SDAI <= 11)
0
   0.0%
0
   0.0%
Baseline : Moderate (11 < SDAI <= 26)
20
  13.5%
16
  12.2%
Baseline : High (SDAI > 26 )
128
  86.5%
115
  87.8%
Week 4 : Remission (SDAI <= 3.3)
2
   1.4%
4
   3.1%
Week 4 : Low (3.3 < SDAI <= 11)
29
  19.6%
27
  20.6%
Week 4 : Moderate (11 < SDAI <= 26
75
  50.7%
69
  52.7%
Week 4 : High (SDAI > 26 )
39
  26.4%
29
  22.1%
Week 12: Remission (SDAI <= 3.3)
14
   9.5%
12
   9.2%
Week 12 : Low (3.3 < SDAI <= 11)
50
  33.8%
51
  38.9%
Week 12 : Moderate (11 < SDAI <= 26
69
  46.6%
53
  40.5%
Week 12 : High (SDAI > 26 )
13
   8.8%
11
   8.4%
Week 24: Remission (SDAI <= 3.3)
31
  20.9%
29
  22.1%
Week 24 : Low (3.3 < SDAI <= 11)
74
  50.0%
71
  54.2%
Week 24 : Moderate (11 < SDAI <= 26
43
  29.1%
29
  22.1%
Week 24 : High (SDAI > 26 )
0
   0.0%
2
   1.5%
Week 36: Remission (SDAI <= 3.3)
34
  23.0%
29
  22.1%
Week 36 : Low (3.3 < SDAI <= 11
69
  46.6%
66
  50.4%
Week 36 : Moderate (11 < SDAI <= 26
43
  29.1%
30
  22.9%
Week 36 : High (SDAI > 26 )
1
   0.7%
5
   3.8%
Week 48: Remission (SDAI <= 3.3)
39
  26.4%
32
  24.4%
Week 48 : Low (3.3 < SDAI <= 11
72
  48.6%
62
  47.3%
Week 48 : Moderate (11 < SDAI <= 26
30
  20.3%
29
  22.1%
Week 48 : High (SDAI > 26 )
6
   4.1%
8
   6.1%
26.Secondary Outcome
Title Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI
Hide Description Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI > 22, moderate disease activity, CDAI > 10 to ≤ 22, low disease activity, CDAI > 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 36 and 48;
Time Frame baseline, week 4, week 12, week 24, week 36 and week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline : Remission (CDAI <=2.8)
0
   0.0%
0
   0.0%
Baseline : Low (2.8 < CDAI <= 10)
0
   0.0%
0
   0.0%
Baseline : Moderate (10 < CDAI <= 22)
14
   9.5%
6
   4.6%
Baseline : High (CDAI > 22 )
134
  90.5%
125
  95.4%
Week 4 : Remission (CDAI <=2.8)
2
   1.4%
3
   2.3%
Week 4 : Low (2.8 < CDAI <= 10)
27
  18.2%
28
  21.4%
Week 4 : Moderate (11 < SDAI <= 26
60
  40.5%
60
  45.8%
Week 4 : High (CDAI > 22 )
58
  39.2%
39
  29.8%
Week 12: Remission (CDAI <=2.8)
12
   8.1%
14
  10.7%
Week 12 : Low (2.8 < CDAI <= 10)
52
  35.1%
47
  35.9%
Week 12 : Moderate (10 < CDAI <= 22)
67
  45.3%
50
  38.2%
Week 12 : High (CDAI > 22 )
17
  11.5%
19
  14.5%
Week 24: Remission (CDAI <=2.8)
29
  19.6%
29
  22.1%
Week 24 : Low (2.8 < CDAI <= 10)
71
  48.0%
68
  51.9%
Week 24 : Moderate (10 < CDAI <= 22)
45
  30.4%
30
  22.9%
Week 24 : High (CDAI > 22 )
3
   2.0%
4
   3.1%
Week 36: Remission (CDAI <=2.8)
32
  21.6%
29
  22.1%
Week 36 : Low (2.8 < CDAI <= 10)
67
  45.3%
63
  48.1%
Week 36 : Moderate (10 < CDAI <= 22)
41
  27.7%
32
  24.4%
Week 36 : High (CDAI > 22 )
7
   4.7%
7
   5.3%
Week 48: Remission (CDAI <=2.8)
37
  25.0%
29
  22.1%
Week 48 : Low (2.8 < CDAI <= 10)
71
  48.0%
63
  48.1%
Week 48 : Moderate (10 < CDAI <= 22)
32
  21.6%
31
  23.7%
Week 48 : High (CDAI > 22 )
7
   4.7%
8
   6.1%
27.Secondary Outcome
Title Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;
Hide Description [Not Specified]
Time Frame baseline, week 4, week 12, week 24, week 36, week 48
Show Outcome Measure DataHide Outcome Measure Data
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 148 participants 130 participants
8
   5.4%
4
   3.1%
Week 4 Number Analyzed 147 participants 129 participants
17
  11.6%
25
  19.4%
Week 12 Number Analyzed 148 participants 130 participants
33
  22.3%
39
  30.0%
Week 24 Number Analyzed 147 participants 128 participants
47
  32.0%
51
  39.8%
Week 36 Number Analyzed 147 participants 130 participants
46
  31.3%
48
  36.9%
Week 48 Number Analyzed 147 participants 129 participants
51
  34.7%
51
  39.5%
28.Secondary Outcome
Title Treatment Period 2 :HAQ Index at Weeks 36 and 48;
Hide Description HAQ: from 0 (best) to 3 (worst)
Time Frame baseline, week 4, week 12, week 24, week 36, week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 148 participants 129 participants
1.47  (0.547) 1.50  (0.554)
Week 4 Number Analyzed 147 participants 129 participants
1.22  (0.554) 1.14  (0.620)
Week 12 Number Analyzed 148 participants 127 participants
1.04  (0.560) 0.97  (0.614)
Week 24 Number Analyzed 147 participants 131 participants
0.88  (0.594) 0.83  (0.603)
Week 36 Number Analyzed 147 participants 130 participants
0.89  (0.584) 0.85  (0.651)
Week 48 Number Analyzed 147 participants 129 participants
0.85  (0.609) 0.84  (0.652)
29.Secondary Outcome
Title Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;
Hide Description FACIT: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue
Time Frame baseline, week 4, week 12, week 24, week 36, week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 138 participants 123 participants
26.6  (9.71) 25.5  (10.78)
Week 4 Number Analyzed 147 participants 130 participants
31.5  (8.72) 31.3  (10.07)
Week 12 Number Analyzed 148 participants 130 participants
34.4  (8.89) 34.1  (9.69)
Week 24 Number Analyzed 148 participants 131 participants
36.6  (8.75) 36.7  (9.05)
Week 36 Number Analyzed 147 participants 131 participants
36.9  (8.79) 36.4  (9.50)
Week 48 Number Analyzed 148 participants 131 participants
38.0  (8.74) 35.8  (9.97)
30.Secondary Outcome
Title Treatment Period 2 : CRP Levels at Week 36 and 48
Hide Description [Not Specified]
Time Frame baseline, week 4, week 12, week 24, week 36, week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 148 participants 131 participants
1.21  (2.244) 1.17  (1.589)
Week 4 Number Analyzed 145 participants 129 participants
0.36  (0.733) 0.42  (0.625)
Week 12 Number Analyzed 146 participants 127 participants
0.36  (0.817) 0.50  (0.910)
Week 24 Number Analyzed 148 participants 131 participants
0.44  (0.964) 0.36  (0.487)
Week 36 Number Analyzed 146 participants 130 participants
0.39  (0.758) 0.39  (0.655)
Week 48 Number Analyzed 148 participants 131 participants
0.35  (0.623) 0.40  (0.878)
31.Secondary Outcome
Title Treatment Period 2 : ESR Levels at Week 36 and 48
Hide Description [Not Specified]
Time Frame baseline, week 4, week 12, week 24, week 36, week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 148 131
Mean (Standard Deviation)
Unit of Measure: mm/h
Baseline Number Analyzed 148 participants 131 participants
42.2  (16.99) 41.7  (17.99)
Week 4 Number Analyzed 147 participants 130 participants
26.8  (16.33) 25.3  (16.11)
Week 12 Number Analyzed 148 participants 130 participants
23.8  (15.07) 23.0  (15.38)
Week 24 Number Analyzed 148 participants 131 participants
21.3  (15.66) 19.3  (12.66)
Week 36 Number Analyzed 147 participants 131 participants
22.1  (16.41) 20.3  (14.28)
Week 48 Number Analyzed 147 participants 129 participants
22.8  (16.66) 20.8  (14.62)
32.Secondary Outcome
Title Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel
Hide Description Frequency of participants with injection site reactions in GP2015 and Enbrel
Time Frame up to 48 weeks
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Safety Set
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 186 190
Measure Type: Count of Participants
Unit of Measure: Participants
participants with at least one ISR
13
   7.0%
37
  19.5%
participants with at least one moderate ISR
1
   0.5%
7
   3.7%
participants with at least one severe ISR
0
   0.0%
0
   0.0%
33.Secondary Outcome
Title Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients
Hide Description To assess the immunogenicity of continuous GP2015 treatment versus a treatment transition from Enbrel to GP2015 after 24 weeks of treatment by measuring the rate of ADA positive participants at Weeks 24, 30, 36 and 48. summary of ADA positive data up to week 48 using a 1% false positive cut point
Time Frame baseline, week 4, week 12, week 24, week 36, week 48
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Safety Set
Arm/Group Title 50mg GP2015 50mg EU-authorized Enbrel
Hide Arm/Group Description:
Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
Overall Number of Participants Analyzed 186 190
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 186 participants 190 participants
2
   1.1%
0
   0.0%
Week 2 Number Analyzed 183 participants 185 participants
2
   1.1%
5
   2.7%
Week 4 Number Analyzed 183 participants 185 participants
3
   1.6%
42
  22.7%
Week 12 Number Analyzed 179 participants 176 participants
0
   0.0%
5
   2.8%
Week 24 Number Analyzed 179 participants 172 participants
0
   0.0%
0
   0.0%
Week 30 Number Analyzed 171 participants 161 participants
2
   1.2%
0
   0.0%
Week 36 Number Analyzed 169 participants 159 participants
0
   0.0%
0
   0.0%
Week 48 Number Analyzed 166 participants 154 participants
2
   1.2%
0
   0.0%
Time Frame Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 1.5 years.
Adverse Event Reporting Description AE additional description
 
Arm/Group Title Treatment Period 1 TP1 SAF GP2015 Treatment Period 1 TP1 SAF Enbrel Treatment Period 2 TP2 SAF Continued GP2015 Treatment Period 2 TP2 SAF Enbrel Switched to GP2015 Entire Study SAF GP2015 Entire Study SAF Enbrel/GP2015
Hide Arm/Group Description Treatment Period 1 TP1 SAF GP2015 Treatment Period 1 TP1 SAF Enbrel Treatment Period 2 TP2 SAF Continued GP2015 Treatment Period 2 TP2 SAF Enbrel switched to GP2015 Entire study SAF GP2015 Entire study SAF Enbrel/GP2015
All-Cause Mortality
Treatment Period 1 TP1 SAF GP2015 Treatment Period 1 TP1 SAF Enbrel Treatment Period 2 TP2 SAF Continued GP2015 Treatment Period 2 TP2 SAF Enbrel Switched to GP2015 Entire Study SAF GP2015 Entire Study SAF Enbrel/GP2015
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/186 (0.00%)   1/190 (0.53%)   0/175 (0.00%)   0/166 (0.00%)   0/186 (0.00%)   1/190 (0.53%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period 1 TP1 SAF GP2015 Treatment Period 1 TP1 SAF Enbrel Treatment Period 2 TP2 SAF Continued GP2015 Treatment Period 2 TP2 SAF Enbrel Switched to GP2015 Entire Study SAF GP2015 Entire Study SAF Enbrel/GP2015
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/186 (0.54%)   5/190 (2.63%)   4/175 (2.29%)   4/166 (2.41%)   5/186 (2.69%)   9/190 (4.74%) 
Cardiac disorders             
Atrial fibrillation  1  0/186 (0.00%)  1/190 (0.53%)  0/175 (0.00%)  0/166 (0.00%)  0/186 (0.00%)  1/190 (0.53%) 
Cardiac failure  1  0/186 (0.00%)  0/190 (0.00%)  0/175 (0.00%)  1/166 (0.60%)  0/186 (0.00%)  1/190 (0.53%) 
Gastrointestinal disorders             
Salivary gland cyst  1  0/186 (0.00%)  0/190 (0.00%)  1/175 (0.57%)  0/166 (0.00%)  1/186 (0.54%)  0/190 (0.00%) 
Hepatobiliary disorders             
Cholecystitis acute  1  0/186 (0.00%)  0/190 (0.00%)  0/175 (0.00%)  1/166 (0.60%)  0/186 (0.00%)  1/190 (0.53%) 
Cholelithiasis  1  0/186 (0.00%)  1/190 (0.53%)  0/175 (0.00%)  0/166 (0.00%)  0/186 (0.00%)  1/190 (0.53%) 
Infections and infestations             
Osteomyelitis  1  0/186 (0.00%)  0/190 (0.00%)  0/175 (0.00%)  1/166 (0.60%)  0/186 (0.00%)  1/190 (0.53%) 
Pneumonia  1  0/186 (0.00%)  0/190 (0.00%)  1/175 (0.57%)  0/166 (0.00%)  1/186 (0.54%)  0/190 (0.00%) 
Injury, poisoning and procedural complications             
Spinal fracture  1  1/186 (0.54%)  0/190 (0.00%)  0/175 (0.00%)  0/166 (0.00%)  1/186 (0.54%)  0/190 (0.00%) 
Tibia fracture  1  0/186 (0.00%)  0/190 (0.00%)  1/175 (0.57%)  0/166 (0.00%)  1/186 (0.54%)  0/190 (0.00%) 
Investigations             
Hepatic enzyme increased  1  0/186 (0.00%)  1/190 (0.53%)  0/175 (0.00%)  0/166 (0.00%)  0/186 (0.00%)  1/190 (0.53%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid arthritis  1  0/186 (0.00%)  1/190 (0.53%)  0/175 (0.00%)  0/166 (0.00%)  0/186 (0.00%)  1/190 (0.53%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Breast cancer  1  0/186 (0.00%)  0/190 (0.00%)  0/175 (0.00%)  1/166 (0.60%)  0/186 (0.00%)  1/190 (0.53%) 
Colon adenoma  1  0/186 (0.00%)  0/190 (0.00%)  0/175 (0.00%)  1/166 (0.60%)  0/186 (0.00%)  1/190 (0.53%) 
Lung neoplasm malignant  1  0/186 (0.00%)  1/190 (0.53%)  0/175 (0.00%)  0/166 (0.00%)  0/186 (0.00%)  1/190 (0.53%) 
Renal and urinary disorders             
Cystitis haemorrhagic  1  0/186 (0.00%)  0/190 (0.00%)  1/175 (0.57%)  0/166 (0.00%)  1/186 (0.54%)  0/190 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Treatment Period 1 TP1 SAF GP2015 Treatment Period 1 TP1 SAF Enbrel Treatment Period 2 TP2 SAF Continued GP2015 Treatment Period 2 TP2 SAF Enbrel Switched to GP2015 Entire Study SAF GP2015 Entire Study SAF Enbrel/GP2015
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/186 (27.96%)   64/190 (33.68%)   42/175 (24.00%)   37/166 (22.29%)   79/186 (42.47%)   81/190 (42.63%) 
Blood and lymphatic system disorders             
Anaemia  1  2/186 (1.08%)  1/190 (0.53%)  2/175 (1.14%)  1/166 (0.60%)  4/186 (2.15%)  2/190 (1.05%) 
Gastrointestinal disorders             
Diarrhoea  1  3/186 (1.61%)  4/190 (2.11%)  1/175 (0.57%)  2/166 (1.20%)  4/186 (2.15%)  6/190 (3.16%) 
General disorders             
Injection site reaction  1  13/186 (6.99%)  35/190 (18.42%)  0/175 (0.00%)  6/166 (3.61%)  13/186 (6.99%)  37/190 (19.47%) 
Infections and infestations             
Bronchitis  1  2/186 (1.08%)  4/190 (2.11%)  2/175 (1.14%)  2/166 (1.20%)  4/186 (2.15%)  6/190 (3.16%) 
Cystitis  1  2/186 (1.08%)  4/190 (2.11%)  2/175 (1.14%)  1/166 (0.60%)  4/186 (2.15%)  5/190 (2.63%) 
Nasopharyngitis  1  9/186 (4.84%)  4/190 (2.11%)  13/175 (7.43%)  9/166 (5.42%)  18/186 (9.68%)  12/190 (6.32%) 
Pharyngitis  1  1/186 (0.54%)  3/190 (1.58%)  2/175 (1.14%)  1/166 (0.60%)  3/186 (1.61%)  4/190 (2.11%) 
Upper respiratory tract infection  1  6/186 (3.23%)  7/190 (3.68%)  9/175 (5.14%)  9/166 (5.42%)  13/186 (6.99%)  15/190 (7.89%) 
Urinary tract infection  1  8/186 (4.30%)  8/190 (4.21%)  7/175 (4.00%)  2/166 (1.20%)  13/186 (6.99%)  8/190 (4.21%) 
Viral upper respiratory tract infection  1  2/186 (1.08%)  0/190 (0.00%)  2/175 (1.14%)  2/166 (1.20%)  4/186 (2.15%)  2/190 (1.05%) 
Investigations             
Alanine aminotransferase increased  1  8/186 (4.30%)  4/190 (2.11%)  4/175 (2.29%)  6/166 (3.61%)  12/186 (6.45%)  8/190 (4.21%) 
Metabolism and nutrition disorders             
Hyperuricaemia  1  3/186 (1.61%)  1/190 (0.53%)  2/175 (1.14%)  0/166 (0.00%)  4/186 (2.15%)  1/190 (0.53%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  5/186 (2.69%)  1/190 (0.53%)  3/175 (1.71%)  0/166 (0.00%)  8/186 (4.30%)  1/190 (0.53%) 
Nervous system disorders             
Headache  1  1/186 (0.54%)  1/190 (0.53%)  0/175 (0.00%)  4/166 (2.41%)  1/186 (0.54%)  5/190 (2.63%) 
Vascular disorders             
Hypertension  1  2/186 (1.08%)  2/190 (1.05%)  2/175 (1.14%)  0/166 (0.00%)  4/186 (2.15%)  2/190 (1.05%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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.
Terms related to publication are part of the contract templates between Sponsor and sites/investigators. In general, these terms outlined that authorship of any publications relating to the clinical study shall be determined by agreement with the Sponsor. Sponsor reserves the right to request amendments or deletions to proposed publications, or request that any publication or presentation be delayed up to four months. A very limited number of exceptions can be granted to modify these terms.
Results Point of Contact
Name/Title: Sandoz Biopharma Clinical Development - Strategic Planning
Organization: Sandoz
Phone: 0049(0)80244760
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT02638259     History of Changes
Other Study ID Numbers: GP15-301
First Submitted: December 16, 2015
First Posted: December 23, 2015
Results First Submitted: December 19, 2017
Results First Posted: February 23, 2018
Last Update Posted: September 19, 2018