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

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

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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Withdrawn per sponsor decision	0	2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).

Baseline Characteristics

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Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel	Total
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
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%

Outcome Measures

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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
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

Outcome Measure Data

Analysis Population Description

Treatment Period 1 Per-Protocol set

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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)

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
Description	Frequency of participants with injection site reactions in GP2015 and Enbrel
Time Frame	Treatment Period 1, up to 24 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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;
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: best is 0,; < 2.6 – remission,; ≥ 2.6 to ≤ 3.2 – low disease activity; > 3.2 to ≤ 5.1 – moderate disease activity; > 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

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	[Not Specified]
Time Frame	baseline, Week 4, week 12, week 24

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	% patients in DAS28-ESR categories up to week 24
Time Frame	week 4, week 12 and week 24

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
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

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
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;

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
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;

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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
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;

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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;
Description	Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)
Time Frame	Weeks 4, 12 and 24;

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
Description	Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)
Time Frame	Baseline, Weeks 4, 12 and 24;

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
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;

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	[Not Specified]
Time Frame	Weeks 4, 12 and 24

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	[Not Specified]
Time Frame	Weeks 4, 12 and 24

Outcome Measure Data

Analysis Population Description

Treatment period 1 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
Description	DAS28-CRP and DAS28-ESR: best is 0,; < 2.6 – remission,; ≥ 2.6 to ≤ 3.2 – low disease activity; > 3.2 to ≤ 5.1 – moderate disease activity; > 5.1 – high disease activity
Time Frame	Baseline, week 4, week 12, week 24, week 36 and week 48.

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	[Not Specified]
Time Frame	week 4, week 12, week 24, week 36, week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
Description	percentage of participants in DAS28-ESR categories up to week 48
Time Frame	week 36 and week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
Description	[Not Specified]
Time Frame	week 36 and week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
Description	ACR-N: negative is worsening, positive (up to 100) is an improvement
Time Frame	week 36 and week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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;
Description	[Not Specified]
Time Frame	baseline, week 4, week 12, week 24, week 36, week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
Description	HAQ: from 0 (best) to 3 (worst)
Time Frame	baseline, week 4, week 12, week 24, week 36, week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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;
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

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	[Not Specified]
Time Frame	baseline, week 4, week 12, week 24, week 36, week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	[Not Specified]
Time Frame	baseline, week 4, week 12, week 24, week 36, week 48

Outcome Measure Data

Analysis Population Description

Treatment period 2 per protocol set. Patients with data available

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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
Description	Frequency of participants with injection site reactions in GP2015 and Enbrel
Time Frame	up to 48 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	50mg GP2015	50mg EU-authorized Enbrel
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
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

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title		50mg GP2015	50mg EU-authorized Enbrel
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%

Adverse Events

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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
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%)
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
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

Limitations and Caveats

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[Not Specified]

More Information

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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

EMail: biopharma.clinicaltrials@sandoz.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matucci-Cerinic M, Allanore Y, Kavanaugh A, Buch MH, Schulze-Koops H, Kucharz EJ, Woehling H, Babic G, Poetzl J, Davis A, Schwebig A. Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study. RMD Open. 2018 Nov 14;4(2):e000757. doi: 10.1136/rmdopen-2018-000757. eCollection 2018.

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