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Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis (ADMYRA)

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ClinicalTrials.gov Identifier: NCT02744755
Recruitment Status : Completed
First Posted : April 20, 2016
Results First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Adalimumab - GP2017
Biological: Adalimumab - US licensed Humira
Enrollment 353
Recruitment Details 353 patients were randomized (1:1)and received at least one dose of study drug; 303 patients completed the study.Eligible patients in the Humira group who completed Study Period 1 (baseline to week 24) with an at least moderate response by DAS28-CRP score were switched to GP2017 treatment during Study Period 2 (Week 24 to week 48).
Pre-assignment Details Full analysis set: randomized patients (study drug assigned) Per protocol set study period 1 (SP1) / study period 2(SP2): patients who completed Week 12 (SP1) / Week 48 (SP2) without major protocol deviations and received at least 5 doses of study drug up to Week 10 (SP1) / 10 doses of IMP from Week 24 to Week 46 (SP2)
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2). Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Period Title: Study Period 1
Started [1] 177 176
Completed [2] 163 168
Not Completed 14 8
Reason Not Completed
Protocol Violation             2             1
not defined             0             1
Pregnancy             1             0
Adverse Event             1             1
Lost to Follow-up             1             1
Lack of Efficacy             1             0
Withdrawal by Subject             8             4
[1]
randomized
[2]
completed study period 1
Period Title: Study Period 2
Started 159 166
Completed 145 158
Not Completed 14 8
Reason Not Completed
Adverse Event             5             0
Protocol Violation             1             0
not defined             3             2
Lost to Follow-up             0             2
Withdrawal by Subject             2             2
Lack of Efficacy             3             2
Arm/Group Title GP2017 Humira / Switched GP2017 Total
Hide Arm/Group Description Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2). Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2). Total of all reporting groups
Overall Number of Baseline Participants 177 176 353
Hide Baseline Analysis Population Description
Baseline characteristics are presented for Study Period 1 Full Analysis Set (SP 1 FAS ). The SP 1 FAS is comprised of all randomized patients to whom study treatment has been assigned.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 176 participants 353 participants
52.8  (12.81) 53.8  (12.22) 53.3  (12.51)
[1]
Measure Analysis Population Description: Baseline characteristics are presented for Study Period 1 Full Analysis Set (SP 1 FAS ). The SP 1 FAS is comprised of all randomized patients to whom study treatment has been assigned.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
Female
153
  86.4%
142
  80.7%
295
  83.6%
Male
24
  13.6%
34
  19.3%
58
  16.4%
[1]
Measure Analysis Population Description: Baseline characteristics are presented for Study Period 1 Full Analysis Set (SP 1 FAS ). The SP 1 FAS is comprised of all randomized patients to whom study treatment has been assigned.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
White
152
  85.9%
152
  86.4%
304
  86.1%
American Indian or Alaska Native
14
   7.9%
15
   8.5%
29
   8.2%
Black or African American
6
   3.4%
3
   1.7%
9
   2.5%
Asian
1
   0.6%
3
   1.7%
4
   1.1%
Other
4
   2.3%
3
   1.7%
7
   2.0%
[1]
Measure Analysis Population Description: Baseline characteristics are presented for Study Period 1 Full Analysis Set (SP 1 FAS ). The SP 1 FAS is comprised of all randomized patients to whom study treatment has been assigned.
1.Primary Outcome
Title Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira
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 (GDA) or general health (GH), 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 or GH + 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 Study period 1: week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Period 1 Per-Protocol set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 140 144
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-2.16  (0.114) -2.18  (0.110)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2017, Humira / Switched GP2017
Comments Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira 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 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.24 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GP2017, Humira / Switched GP2017
Comments Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira 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 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.19 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.129
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira
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 (GDA) or general health (GH), 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 or GH + 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 Study period 1: week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Period 1 Per-Protocol set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.85  (0.098) -1.93  (0.092)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2017, Humira / Switched GP2017
Comments ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.
Type of Statistical Test Equivalence
Comments A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.11 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.096
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GP2017, Humira / Switched GP2017
Comments ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.
Type of Statistical Test Equivalence
Comments A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 90%
-0.08 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.096
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission
Hide Description Proportion of patients achieving European League against Rheumatism (EULAR) remission (defined as DAS28 CRP < 2.6 )
Time Frame week 4, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
EULAR remission week 4 Number Analyzed 123 participants 138 participants
15
  12.2%
7
   5.1%
EULAR remission week 12 Number Analyzed 126 participants 138 participants
32
  25.4%
38
  27.5%
EULAR remission week 24 Number Analyzed 127 participants 138 participants
49
  38.6%
71
  51.4%
4.Secondary Outcome
Title Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response
Hide Description Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28<=3.2 at post-baseline assessment timepoint(s) with an improvement of >1.2 in DAS28 from baseline.)
Time Frame week 4, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
Good response week 4 Number Analyzed 123 participants 138 participants
22
  17.9%
25
  18.1%
Good response week 12 Number Analyzed 126 participants 138 participants
51
  40.5%
63
  45.7%
Good response week 24 Number Analyzed 126 participants 138 participants
76
  60.3%
93
  67.4%
5.Secondary Outcome
Title Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response
Hide Description Proportion of patients achieving European League against Rheumatism (EULAR) moderate response (defined as DAS28<=3.2 at post-baseline assessment timepoint(s) with an improvement of >0.6 to <=1.2 from baseline or DAS28 >3.2 to <=5.1 with an improvement of >0.6 to <=1.2 or of >1.2 from baseline or DAS28 >5.1 with an improvement of >1.2 from baseline) ;
Time Frame week 4, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
Moderate response week 4 Number Analyzed 123 participants 138 participants
63
  51.2%
78
  56.5%
Moderate response week 12 Number Analyzed 126 participants 138 participants
64
  50.8%
62
  44.9%
Moderate response week 24 Number Analyzed 126 participants 138 participants
42
  33.3%
42
  30.4%
6.Secondary Outcome
Title Study 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 joint count 28 <=1 and swollen joint count 28 <=1, CRP level (mg/dL) <=1 and patient's global assessment <=1 on a scale of 1-10 (corresponding to <=10 on a scale of 1-100).
Time Frame week 4, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
week 4 Number Analyzed 123 participants 138 participants
4
   3.3%
0
   0.0%
week 12 Number Analyzed 126 participants 138 participants
8
   6.3%
12
   8.7%
week 24 Number Analyzed 127 participants 138 participants
19
  15.0%
26
  18.8%
7.Secondary Outcome
Title Study Period 1: Change in DAS28-CRP and DAS28-ESR Scores From Baseline to Week 24 in Patients Treated With GP2017 and Patients Treated With Humira
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.Values range from 0 to 10. Higher values mean a higher disease activity.

Time Frame study period 1: week 2, 4, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Period 1 Per-Protocol set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
DAS28 CRP week 2 Number Analyzed 122 participants 137 participants
-0.86  (0.107) -0.92  (0.101)
DAS28 CRP week 4 Number Analyzed 123 participants 138 participants
-1.31  (0.112) -1.36  (0.105)
DAS28 CRP week 24 Number Analyzed 127 participants 138 participants
-2.61  (0.109) -2.83  (0.103)
DAS28 ESR week 2 Number Analyzed 125 participants 137 participants
-0.94  (0.115) -0.98  (0.109)
DAS28 ESR week 4 Number Analyzed 125 participants 138 participants
-1.51  (0.124) -1.51  (0.117)
DAS28 ESR week 24 Number Analyzed 126 participants 138 participants
-2.97  (0.127) -3.16  (0.120)
8.Secondary Outcome
Title Study 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: -at least 20% improvement in tender 68 joint count

-at least 20% improvement in swollen 66 joint-count; And at least 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 index(HAQ-DI© 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
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
ACR20 response Week 4 Number Analyzed 126 participants 138 participants
64
  50.8%
71
  51.4%
ACR20 response Week 12 Number Analyzed 127 participants 138 participants
100
  78.7%
106
  76.8%
ACR20 response Week 24 Number Analyzed 127 participants 138 participants
111
  87.4%
130
  94.2%
ACR50 response Week 4 Number Analyzed 126 participants 138 participants
25
  19.8%
25
  18.1%
ACR50 response Week 12 Number Analyzed 127 participants 138 participants
53
  41.7%
67
  48.6%
ACR50 response Week 24 Number Analyzed 127 participants 138 participants
78
  61.4%
98
  71.0%
ACR70 response Week 4 Number Analyzed 126 participants 138 participants
7
   5.6%
9
   6.5%
ACR70 response Week 12 Number Analyzed 127 participants 138 participants
24
  18.9%
35
  25.4%
ACR70 response Week 24 Number Analyzed 127 participants 138 participants
48
  37.8%
53
  38.4%
9.Secondary Outcome
Title Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;
Hide Description

Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst).The HAQ© was scored in accordance with the recommendation from the developers outlined in the “HAQ PACK” from Stanford University, California.

Ramey Dr, Fries JF, Singh G. in B. Spilker Quality of Life and Pharmacoleconomics in Clinical Trials, 2nd ed, The Health Assessment Questionnaire 1995 -- Status and Review. Philadelphia: Lippincott-Raven Pub., 1996, p 227 – 237.

Fries JF, Spitz P, Kraines G, Holman H. Measurement of Patient Outcome in Arthritis, Arthritis and Rheumatism, 1980, 23:137-145.

Time Frame Weeks 4, 12 and 24;
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 -0.32  (0.519) -0.32  (0.449)
Week 12 -0.50  (0.576) -0.47  (0.501)
Week 24 -0.63  (0.610) -0.59  (0.543)
10.Secondary Outcome
Title Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Hide Description Health assessment questionnaire disability index (HAQ-DI©) ranges from 0 (best) to 3 (worst)
Time Frame Weeks 4, 12 and 24;
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 125 participants 138 participants
27
  21.6%
33
  23.9%
Week 12 Number Analyzed 127 participants 138 participants
38
  29.9%
40
  29.0%
Week 24 Number Analyzed 127 participants 138 participants
46
  36.2%
50
  36.2%
11.Secondary Outcome
Title Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24
Hide Description Health assessment questionnaire (HAQ-DI©) disability index ranges from 0 (best) to 3 (worst)
Time Frame Weeks 4, 12 and 24;
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 125 participants 138 participants
106
  84.8%
117
  84.8%
Week 12 Number Analyzed 127 participants 138 participants
102
  80.3%
109
  79.0%
Week 24 Number Analyzed 127 participants 138 participants
91
  71.7%
106
  76.8%
12.Secondary Outcome
Title Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)
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).
Time Frame Weeks 4, 12 and 24;
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Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 6.59  (7.949) 7.25  (8.591)
Week 12 10.49  (9.218) 10.62  (9.134)
Week 24 12.57  (10.760) 12.72  (9.451)
13.Secondary Outcome
Title Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
Hide Description Outcome measure 13 presents changes in CRP measures in blood while Outome measure 7 presents changes in DAS28-CRP scores (calculated composite score to measure the disease activity)
Time Frame Week 4, week 12, week 24
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Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Mean (Standard Deviation)
Unit of Measure: mg/L
CRP change from baseline week 4 -4.79  (8.728) -4.93  (12.128)
CRP change from baseline week 12 -5.98  (11.270) -5.07  (11.791)
CRP change from baseline week 24 -2.51  (19.176) -5.30  (13.726)
14.Secondary Outcome
Title Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
Hide Description Outcome measure 13 presents changes in ESR measures in blood while outcome measure 7 presents changes in DAS28-ESR scores (calculated composite score to measure the disease activity)
Time Frame Week 4, week 12, week 24
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Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 127 138
Mean (Standard Deviation)
Unit of Measure: mm/h
ESR change from baseline week 4 -16.17  (14.693) -13.98  (15.823)
ESR change from baseline week 12 -17.33  (16.214) -15.08  (31.150)
ESR change from baseline week 24 -19.60  (20.494) -20.49  (18.255)
15.Secondary Outcome
Title Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Hide Description Incidence of injection site reactions in GP2017 and Humira
Time Frame Treatment Period 1, 24 weeks
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Safety Set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 177 176
Measure Type: Count of Participants
Unit of Measure: Participants
incidence of injection site reactions
7
   4.0%
11
   6.3%
injection site reactions MILD
7
   4.0%
7
   4.0%
injection site reactions MODERATE
0
   0.0%
4
   2.3%
injection site reactions SEVERE
0
   0.0%
0
   0.0%
Injection site erythema
2
   1.1%
6
   3.4%
Injection site pruritus
2
   1.1%
3
   1.7%
Injection site pain
2
   1.1%
1
   0.6%
Injection site inflammation
2
   1.1%
0
   0.0%
Injection site rash
0
   0.0%
2
   1.1%
Injection site discolouration
0
   0.0%
1
   0.6%
16.Secondary Outcome
Title Study Period 1 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 or Humira (Positive Patients)
Hide Description Frequency of patients having anti-drug antibody (ADA) during 24 weeks
Time Frame baseline, week 2, week 4, week 12, week 24
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Safety Set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 177 176
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 176 participants 174 participants
10
   5.7%
6
   3.4%
Week 2 Number Analyzed 160 participants 166 participants
12
   7.5%
10
   6.0%
Week 4 Number Analyzed 159 participants 166 participants
14
   8.8%
22
  13.3%
Week 12 Number Analyzed 157 participants 164 participants
16
  10.2%
23
  14.0%
Week 24 Number Analyzed 151 participants 162 participants
23
  15.2%
25
  15.4%
17.Secondary Outcome
Title Study Period 2 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira (Positive Patients)
Hide Description Frequency of patients having anti-drug antibody (ADA) during 24 weeks
Time Frame week 24, week 36, week 48
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Safety Set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 159 166
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 148 participants 160 participants
22
  14.9%
25
  15.6%
Week 36 Number Analyzed 140 participants 153 participants
21
  15.0%
22
  14.4%
Week 48 Number Analyzed 113 participants 127 participants
12
  10.6%
12
   9.4%
18.Secondary Outcome
Title Study Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Week 48, in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira
Hide Description [Not Specified]
Time Frame week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 108 126
Measure Type: Count of Participants
Unit of Measure: Participants
ACR20 response Week 48
93
  86.1%
111
  88.1%
ACR50 response Week 48
72
  66.7%
81
  64.3%
ACR70 response Week 48
49
  45.4%
55
  43.7%
19.Secondary Outcome
Title Study Period 2 - Health Assessment Questionnaire-Disability Index (HAQ-DI©) Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Hide Description Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst)
Time Frame Weeks 48
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Treatment period 1 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
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Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 108 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.01  (0.358) -0.03  (0.427)
20.Secondary Outcome
Title Study Period 2 :Proportion of Patients Treated Continuously With GP2017 and Patients Treated With GP2017 After Switch From Humira Achieving HAQ-DI© Score in Normal Range ≤0.5 at Week 48
Hide Description [Not Specified]
Time Frame week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 108 126
Measure Type: Count of Participants
Unit of Measure: Participants
45
  41.7%
52
  41.3%
21.Secondary Outcome
Title Study Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Hide Description FACIT©: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue
Time Frame week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 108 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.65  (7.421) -0.85  (7.476)
22.Secondary Outcome
Title Study Period 2: Changes From Week 24 at Week 48 in DAS28-CRP and DAS28-ESR Scores in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
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.Values range from 0 to 10. Higher values mean a higher disease activity.

Time Frame week 48
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Treatment period 2 per protocol set. Patients with data available
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 108 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
DAS28-CRP Week 48, change from week 24 Number Analyzed 107 participants 125 participants
-0.10  (0.893) 0.00  (0.941)
DAS28-ESR Week 48, change from week 24 Number Analyzed 108 participants 126 participants
-0.04  (1.015) 0.00  (1.025)
23.Secondary Outcome
Title Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Hide Description Incidence of injection site reactions
Time Frame up to 48 weeks
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Safety Set
Arm/Group Title GP2017 Humira / Switched GP2017
Hide Arm/Group Description:
Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
Overall Number of Participants Analyzed 159 166
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with ISRs
1
   0.6%
2
   1.2%
Injection site erythema
1
   0.6%
2
   1.2%
Injection site pruritus
0
   0.0%
1
   0.6%
injection site reactions MILD
1
   0.6%
1
   0.6%
injection site reactions MODERATE
0
   0.0%
1
   0.6%
injection site reactions SEVERE
0
   0.0%
0
   0.0%
Time Frame Each patient was followed up for safety during the whole study treatment duration ( approximately 24 months) , and Adverse Events were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) for every single patient, + 30 day safety follow up period after study treatment discontinuation.
Adverse Event Reporting Description AE additional description
 
Arm/Group Title Study Period 1 SP1 SAF GP2017 Study Period 1 SP1 SAF Humira Study Period 2 SP2 SAF Continued GP2017 Study Period 2 SP2 SAF Humira to GP2017 Entire Study SP1 SAF GP2017 Entire Study SP1 SAF Humira/Switched GP2017
Hide Arm/Group Description Study Period 1 SP1 SAF GP2017 Study Period 1 SP1 SAF Humira Study Period 2 SP2 SAF Continued GP2017 Study Period 2 SP2 SAF Humira to GP2017 Entire study SP1 SAF GP2017 Entire study SP1 SAF Humira/Switched GP2017
All-Cause Mortality
Study Period 1 SP1 SAF GP2017 Study Period 1 SP1 SAF Humira Study Period 2 SP2 SAF Continued GP2017 Study Period 2 SP2 SAF Humira to GP2017 Entire Study SP1 SAF GP2017 Entire Study SP1 SAF Humira/Switched GP2017
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/177 (0.00%)   0/176 (0.00%)   0/159 (0.00%)   0/166 (0.00%)   0/177 (0.00%)   0/176 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Study Period 1 SP1 SAF GP2017 Study Period 1 SP1 SAF Humira Study Period 2 SP2 SAF Continued GP2017 Study Period 2 SP2 SAF Humira to GP2017 Entire Study SP1 SAF GP2017 Entire Study SP1 SAF Humira/Switched GP2017
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/177 (2.82%)   4/176 (2.27%)   4/159 (2.52%)   6/166 (3.61%)   7/177 (3.95%)   10/176 (5.68%) 
Cardiac disorders             
Angina pectoris  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  1/176 (0.57%) 
Gastrointestinal disorders             
Constipation  1  1/177 (0.56%)  0/176 (0.00%)  1/159 (0.63%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Diarrhoea  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  1/176 (0.57%) 
Pancreatitis acute  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  1/176 (0.57%) 
Upper gastrointestinal haemorrhage  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Hepatobiliary disorders             
Cholecystitis  1  1/177 (0.56%)  0/176 (0.00%)  0/159 (0.00%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Hepatitis  1  1/177 (0.56%)  0/176 (0.00%)  0/159 (0.00%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Infections and infestations             
Bronchitis  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  1/176 (0.57%) 
Diverticulitis  1  0/177 (0.00%)  0/176 (0.00%)  1/159 (0.63%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Pneumonia  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  2/166 (1.20%)  0/177 (0.00%)  2/176 (1.14%) 
Pneumonia bacterial  1  1/177 (0.56%)  0/176 (0.00%)  0/159 (0.00%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Injury, poisoning and procedural complications             
Humerus fracture  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Lumbar vertebral fracture  1  0/177 (0.00%)  0/176 (0.00%)  1/159 (0.63%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Metabolism and nutrition disorders             
Hyponatraemia  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  1/176 (0.57%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  1/177 (0.56%)  0/176 (0.00%)  0/159 (0.00%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Brain neoplasm benign  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Uterine leiomyoma  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Nervous system disorders             
Encephalopathy  1  0/177 (0.00%)  0/176 (0.00%)  1/159 (0.63%)  0/166 (0.00%)  1/177 (0.56%)  0/176 (0.00%) 
Epilepsy  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Hemianopia homonymous  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Intracranial pressure increased  1  0/177 (0.00%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  0/177 (0.00%)  1/176 (0.57%) 
Reproductive system and breast disorders             
Uterine prolapse  1  0/177 (0.00%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  1/176 (0.57%) 
1
Term from vocabulary, MedDRA (20.0)
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%
Study Period 1 SP1 SAF GP2017 Study Period 1 SP1 SAF Humira Study Period 2 SP2 SAF Continued GP2017 Study Period 2 SP2 SAF Humira to GP2017 Entire Study SP1 SAF GP2017 Entire Study SP1 SAF Humira/Switched GP2017
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   83/177 (46.89%)   74/176 (42.05%)   28/159 (17.61%)   26/166 (15.66%)   94/177 (53.11%)   80/176 (45.45%) 
Blood and lymphatic system disorders             
Leukopenia  1  2/177 (1.13%)  0/176 (0.00%)  2/159 (1.26%)  0/166 (0.00%)  4/177 (2.26%)  0/176 (0.00%) 
Neutropenia  1  3/177 (1.69%)  0/176 (0.00%)  2/159 (1.26%)  0/166 (0.00%)  5/177 (2.82%)  0/176 (0.00%) 
Gastrointestinal disorders             
Diarrhoea  1  4/177 (2.26%)  7/176 (3.98%)  0/159 (0.00%)  0/166 (0.00%)  4/177 (2.26%)  7/176 (3.98%) 
Nausea  1  5/177 (2.82%)  1/176 (0.57%)  0/159 (0.00%)  0/166 (0.00%)  5/177 (2.82%)  1/176 (0.57%) 
General disorders             
Fatigue  1  5/177 (2.82%)  0/176 (0.00%)  0/159 (0.00%)  1/166 (0.60%)  5/177 (2.82%)  1/176 (0.57%) 
Injection site erythema  1  2/177 (1.13%)  6/176 (3.41%)  1/159 (0.63%)  2/166 (1.20%)  3/177 (1.69%)  6/176 (3.41%) 
Infections and infestations             
Bronchitis  1  4/177 (2.26%)  8/176 (4.55%)  1/159 (0.63%)  4/166 (2.41%)  4/177 (2.26%)  12/176 (6.82%) 
Gastroenteritis  1  2/177 (1.13%)  4/176 (2.27%)  1/159 (0.63%)  0/166 (0.00%)  3/177 (1.69%)  4/176 (2.27%) 
Influenza  1  3/177 (1.69%)  5/176 (2.84%)  1/159 (0.63%)  0/166 (0.00%)  4/177 (2.26%)  5/176 (2.84%) 
Oral herpes  1  4/177 (2.26%)  3/176 (1.70%)  1/159 (0.63%)  0/166 (0.00%)  5/177 (2.82%)  3/176 (1.70%) 
Pharyngitis  1  9/177 (5.08%)  10/176 (5.68%)  1/159 (0.63%)  3/166 (1.81%)  10/177 (5.65%)  10/176 (5.68%) 
Sinusitis  1  5/177 (2.82%)  3/176 (1.70%)  0/159 (0.00%)  2/166 (1.20%)  5/177 (2.82%)  5/176 (2.84%) 
Upper respiratory tract infection  1  12/177 (6.78%)  7/176 (3.98%)  4/159 (2.52%)  3/166 (1.81%)  14/177 (7.91%)  9/176 (5.11%) 
Urinary tract infection  1  4/177 (2.26%)  6/176 (3.41%)  2/159 (1.26%)  3/166 (1.81%)  6/177 (3.39%)  8/176 (4.55%) 
Viral upper respiratory tract infection  1  26/177 (14.69%)  16/176 (9.09%)  4/159 (2.52%)  4/166 (2.41%)  29/177 (16.38%)  19/176 (10.80%) 
Injury, poisoning and procedural complications             
Fall  1  2/177 (1.13%)  3/176 (1.70%)  0/159 (0.00%)  1/166 (0.60%)  2/177 (1.13%)  4/176 (2.27%) 
Investigations             
Transaminases increased  1  0/177 (0.00%)  3/176 (1.70%)  1/159 (0.63%)  1/166 (0.60%)  1/177 (0.56%)  4/176 (2.27%) 
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  3/177 (1.69%)  3/176 (1.70%)  2/159 (1.26%)  0/166 (0.00%)  5/177 (2.82%)  3/176 (1.70%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  8/177 (4.52%)  0/176 (0.00%)  2/159 (1.26%)  0/166 (0.00%)  10/177 (5.65%)  0/176 (0.00%) 
Rheumatoid arthritis  1  3/177 (1.69%)  1/176 (0.57%)  5/159 (3.14%)  2/166 (1.20%)  6/177 (3.39%)  3/176 (1.70%) 
Nervous system disorders             
Headache  1  7/177 (3.95%)  5/176 (2.84%)  2/159 (1.26%)  2/166 (1.20%)  8/177 (4.52%)  7/176 (3.98%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/177 (1.13%)  1/176 (0.57%)  3/159 (1.89%)  0/166 (0.00%)  5/177 (2.82%)  1/176 (0.57%) 
Skin and subcutaneous tissue disorders             
Urticaria  1  0/177 (0.00%)  3/176 (1.70%)  0/159 (0.00%)  1/166 (0.60%)  0/177 (0.00%)  4/176 (2.27%) 
Vascular disorders             
Hypertension  1  5/177 (2.82%)  3/176 (1.70%)  2/159 (1.26%)  1/166 (0.60%)  6/177 (3.39%)  4/176 (2.27%) 
1
Term from vocabulary, MedDRA (20.0)
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sandoz Biopharma Clinical Development - Strategic Planning
Organization: Hexal AG/Sandoz Inc.
Phone: 0049(0)80244760
EMail: biopharma.clinicaltrials@sandoz.com
Layout table for additonal information
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT02744755     History of Changes
Other Study ID Numbers: GP17-302
2015-003433-10 ( EudraCT Number )
First Submitted: April 12, 2016
First Posted: April 20, 2016
Results First Submitted: September 21, 2018
Results First Posted: December 18, 2018
Last Update Posted: December 18, 2018