Trial Outcomes & Findings for Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis (NCT NCT02744755)
NCT ID: NCT02744755
Last Updated: 2018-12-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
353 participants
Primary outcome timeframe
Study period 1: week 12
Results posted on
2018-12-19
Participant Flow
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).
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)
Participant milestones
| Measure |
GP2017
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).
|
Humira / Switched GP2017
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).
|
|---|---|---|
|
Study Period 1
STARTED
|
177
|
176
|
|
Study Period 1
COMPLETED
|
163
|
168
|
|
Study Period 1
NOT COMPLETED
|
14
|
8
|
|
Study Period 2
STARTED
|
159
|
166
|
|
Study Period 2
COMPLETED
|
145
|
158
|
|
Study Period 2
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
| Measure |
GP2017
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).
|
Humira / Switched GP2017
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).
|
|---|---|---|
|
Study Period 1
Protocol Violation
|
2
|
1
|
|
Study Period 1
not defined
|
0
|
1
|
|
Study Period 1
Pregnancy
|
1
|
0
|
|
Study Period 1
Adverse Event
|
1
|
1
|
|
Study Period 1
Lost to Follow-up
|
1
|
1
|
|
Study Period 1
Lack of Efficacy
|
1
|
0
|
|
Study Period 1
Withdrawal by Subject
|
8
|
4
|
|
Study Period 2
Adverse Event
|
5
|
0
|
|
Study Period 2
Protocol Violation
|
1
|
0
|
|
Study Period 2
not defined
|
3
|
2
|
|
Study Period 2
Lost to Follow-up
|
0
|
2
|
|
Study Period 2
Withdrawal by Subject
|
2
|
2
|
|
Study Period 2
Lack of Efficacy
|
3
|
2
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
GP2017
n=177 Participants
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).
|
Humira / Switched GP2017
n=176 Participants
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
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 12.81 • n=5 Participants • 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.
|
53.8 years
STANDARD_DEVIATION 12.22 • n=7 Participants • 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.
|
53.3 years
STANDARD_DEVIATION 12.51 • n=5 Participants • 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
Female
|
153 Participants
n=5 Participants • 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.
|
142 Participants
n=7 Participants • 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.
|
295 Participants
n=5 Participants • 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
Male
|
24 Participants
n=5 Participants • 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.
|
34 Participants
n=7 Participants • 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.
|
58 Participants
n=5 Participants • 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
White
|
152 Participants
n=5 Participants • 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.
|
152 Participants
n=7 Participants • 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.
|
304 Participants
n=5 Participants • 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
American Indian or Alaska Native
|
14 Participants
n=5 Participants • 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.
|
15 Participants
n=7 Participants • 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.
|
29 Participants
n=5 Participants • 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
Black or African American
|
6 Participants
n=5 Participants • 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.
|
3 Participants
n=7 Participants • 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.
|
9 Participants
n=5 Participants • 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
Asian
|
1 Participants
n=5 Participants • 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.
|
3 Participants
n=7 Participants • 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.
|
4 Participants
n=5 Participants • 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
Other
|
4 Participants
n=5 Participants • 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.
|
3 Participants
n=7 Participants • 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.
|
7 Participants
n=5 Participants • 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.
|
PRIMARY outcome
Timeframe: Study period 1: week 12Population: Treatment Period 1 Per-Protocol set
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
Outcome measures
| Measure |
Humira / Switched GP2017
n=144 Participants
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).
|
GP2017
n=140 Participants
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).
|
|---|---|---|
|
Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira
|
-2.18 scores on a scale
Standard Error 0.110
|
-2.16 scores on a scale
Standard Error 0.114
|
SECONDARY outcome
Timeframe: Study period 1: week 24Population: Treatment Period 1 Per-Protocol set
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
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira
|
-1.93 scores on a scale
Standard Error 0.092
|
-1.85 scores on a scale
Standard Error 0.098
|
SECONDARY outcome
Timeframe: week 4, week 12 and week 24Population: Treatment period 1 per protocol set. Patients with data available
Proportion of patients achieving European League against Rheumatism (EULAR) remission (defined as DAS28 CRP \< 2.6 )
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission
EULAR remission week 12
|
38 Participants
|
32 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission
EULAR remission week 24
|
71 Participants
|
49 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission
EULAR remission week 4
|
7 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 4, week 12 and week 24Population: Treatment period 1 per protocol set. Patients with data available
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.)
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response
Good response week 4
|
25 Participants
|
22 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response
Good response week 12
|
63 Participants
|
51 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response
Good response week 24
|
93 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: week 4, week 12 and week 24Population: Treatment period 1 per protocol set. Patients with data available
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) ;
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response
Moderate response week 4
|
78 Participants
|
63 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response
Moderate response week 12
|
62 Participants
|
64 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response
Moderate response week 24
|
42 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: week 4, week 12, week 24Population: Treatment period 1 per protocol set. Patients with data available
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).
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
week 12
|
12 Participants
|
8 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
week 4
|
0 Participants
|
4 Participants
|
|
Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
week 24
|
26 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: study period 1: week 2, 4, 24Population: Treatment Period 1 Per-Protocol set
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.
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
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
DAS28 CRP week 2
|
-0.92 scores on a scale
Standard Error 0.101
|
-0.86 scores on a scale
Standard Error 0.107
|
|
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
DAS28 CRP week 4
|
-1.36 scores on a scale
Standard Error 0.105
|
-1.31 scores on a scale
Standard Error 0.112
|
|
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
DAS28 CRP week 24
|
-2.83 scores on a scale
Standard Error 0.103
|
-2.61 scores on a scale
Standard Error 0.109
|
|
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
DAS28 ESR week 2
|
-0.98 scores on a scale
Standard Error 0.109
|
-0.94 scores on a scale
Standard Error 0.115
|
|
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
DAS28 ESR week 4
|
-1.51 scores on a scale
Standard Error 0.117
|
-1.51 scores on a scale
Standard Error 0.124
|
|
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
DAS28 ESR week 24
|
-3.16 scores on a scale
Standard Error 0.120
|
-2.97 scores on a scale
Standard Error 0.127
|
SECONDARY outcome
Timeframe: Week 4, week 12 and week 24Population: Treatment period 1 per protocol set. Patients with data available
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.
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR20 response Week 4
|
71 Participants
|
64 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR20 response Week 12
|
106 Participants
|
100 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR20 response Week 24
|
130 Participants
|
111 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR50 response Week 4
|
25 Participants
|
25 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR50 response Week 12
|
67 Participants
|
53 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR50 response Week 24
|
98 Participants
|
78 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR70 response Week 4
|
9 Participants
|
7 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR70 response Week 12
|
35 Participants
|
24 Participants
|
|
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
ACR70 response Week 24
|
53 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 24;Population: Treatment period 1 per protocol set. Patients with data available
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.
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;
Week 4
|
-0.32 score on a scale
Standard Deviation 0.449
|
-0.32 score on a scale
Standard Deviation 0.519
|
|
Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;
Week 12
|
-0.47 score on a scale
Standard Deviation 0.501
|
-0.50 score on a scale
Standard Deviation 0.576
|
|
Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;
Week 24
|
-0.59 score on a scale
Standard Deviation 0.543
|
-0.63 score on a scale
Standard Deviation 0.610
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 24;Population: Treatment period 1 per protocol set. Patients with data available
Health assessment questionnaire disability index (HAQ-DI©) ranges from 0 (best) to 3 (worst)
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Week 4
|
33 Participants
|
27 Participants
|
|
Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Week 12
|
40 Participants
|
38 Participants
|
|
Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Week 24
|
50 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 24;Population: Treatment period 1 per protocol set. Patients with data available
Health assessment questionnaire (HAQ-DI©) disability index ranges from 0 (best) to 3 (worst)
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24
Week 4
|
117 Participants
|
106 Participants
|
|
Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24
Week 12
|
109 Participants
|
102 Participants
|
|
Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24
Week 24
|
106 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 24;Population: Treatment period 1 per protocol set. Patients with data available
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).
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)
Week 4
|
7.25 score on a scale
Standard Deviation 8.591
|
6.59 score on a scale
Standard Deviation 7.949
|
|
Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)
Week 12
|
10.62 score on a scale
Standard Deviation 9.134
|
10.49 score on a scale
Standard Deviation 9.218
|
|
Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)
Week 24
|
12.72 score on a scale
Standard Deviation 9.451
|
12.57 score on a scale
Standard Deviation 10.760
|
SECONDARY outcome
Timeframe: Week 4, week 12, week 24Population: Treatment period 1 per protocol set. Patients with data available
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)
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
CRP change from baseline week 12
|
-5.07 mg/L
Standard Deviation 11.791
|
-5.98 mg/L
Standard Deviation 11.270
|
|
Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
CRP change from baseline week 24
|
-5.30 mg/L
Standard Deviation 13.726
|
-2.51 mg/L
Standard Deviation 19.176
|
|
Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
CRP change from baseline week 4
|
-4.93 mg/L
Standard Deviation 12.128
|
-4.79 mg/L
Standard Deviation 8.728
|
SECONDARY outcome
Timeframe: Week 4, week 12, week 24Population: Treatment period 1 per protocol set. Patients with data available
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)
Outcome measures
| Measure |
Humira / Switched GP2017
n=138 Participants
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).
|
GP2017
n=127 Participants
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).
|
|---|---|---|
|
Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
ESR change from baseline week 4
|
-13.98 mm/h
Standard Deviation 15.823
|
-16.17 mm/h
Standard Deviation 14.693
|
|
Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
ESR change from baseline week 12
|
-15.08 mm/h
Standard Deviation 31.150
|
-17.33 mm/h
Standard Deviation 16.214
|
|
Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
ESR change from baseline week 24
|
-20.49 mm/h
Standard Deviation 18.255
|
-19.60 mm/h
Standard Deviation 20.494
|
SECONDARY outcome
Timeframe: Treatment Period 1, 24 weeksPopulation: Safety Set
Incidence of injection site reactions in GP2017 and Humira
Outcome measures
| Measure |
Humira / Switched GP2017
n=176 Participants
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).
|
GP2017
n=177 Participants
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).
|
|---|---|---|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
incidence of injection site reactions
|
11 Participants
|
7 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
injection site reactions MILD
|
7 Participants
|
7 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
injection site reactions MODERATE
|
4 Participants
|
0 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
injection site reactions SEVERE
|
0 Participants
|
0 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Injection site erythema
|
6 Participants
|
2 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Injection site pruritus
|
3 Participants
|
2 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Injection site pain
|
1 Participants
|
2 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Injection site inflammation
|
0 Participants
|
2 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Injection site rash
|
2 Participants
|
0 Participants
|
|
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Injection site discolouration
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, week 2, week 4, week 12, week 24Population: Safety Set
Frequency of patients having anti-drug antibody (ADA) during 24 weeks
Outcome measures
| Measure |
Humira / Switched GP2017
n=176 Participants
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).
|
GP2017
n=177 Participants
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).
|
|---|---|---|
|
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)
Baseline
|
6 Participants
|
10 Participants
|
|
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)
Week 2
|
10 Participants
|
12 Participants
|
|
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)
Week 4
|
22 Participants
|
14 Participants
|
|
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)
Week 12
|
23 Participants
|
16 Participants
|
|
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)
Week 24
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: week 24, week 36, week 48Population: Safety Set
Frequency of patients having anti-drug antibody (ADA) during 24 weeks
Outcome measures
| Measure |
Humira / Switched GP2017
n=166 Participants
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).
|
GP2017
n=159 Participants
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).
|
|---|---|---|
|
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)
Week 24
|
25 Participants
|
22 Participants
|
|
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)
Week 36
|
22 Participants
|
21 Participants
|
|
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)
Week 48
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: week 48Population: Treatment period 2 per protocol set. Patients with data available
Outcome measures
| Measure |
Humira / Switched GP2017
n=126 Participants
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).
|
GP2017
n=108 Participants
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).
|
|---|---|---|
|
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
ACR20 response Week 48
|
111 Participants
|
93 Participants
|
|
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
ACR50 response Week 48
|
81 Participants
|
72 Participants
|
|
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
ACR70 response Week 48
|
55 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Weeks 48Population: Treatment period 1 per protocol set. Patients with data available
Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst)
Outcome measures
| Measure |
Humira / Switched GP2017
n=126 Participants
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).
|
GP2017
n=108 Participants
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).
|
|---|---|---|
|
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
|
-0.03 score on a scale
Standard Deviation 0.427
|
0.01 score on a scale
Standard Deviation 0.358
|
SECONDARY outcome
Timeframe: week 48Population: Treatment period 2 per protocol set. Patients with data available
Outcome measures
| Measure |
Humira / Switched GP2017
n=126 Participants
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).
|
GP2017
n=108 Participants
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).
|
|---|---|---|
|
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
|
52 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: week 48Population: Treatment period 2 per protocol set. Patients with data available
FACIT©: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue
Outcome measures
| Measure |
Humira / Switched GP2017
n=126 Participants
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).
|
GP2017
n=108 Participants
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).
|
|---|---|---|
|
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
|
-0.85 score on a scale
Standard Deviation 7.476
|
-0.65 score on a scale
Standard Deviation 7.421
|
SECONDARY outcome
Timeframe: week 48Population: Treatment period 2 per protocol set. Patients with data available
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.
Outcome measures
| Measure |
Humira / Switched GP2017
n=126 Participants
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).
|
GP2017
n=108 Participants
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).
|
|---|---|---|
|
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
DAS28-CRP Week 48, change from week 24
|
0.00 score on a scale
Standard Deviation 0.941
|
-0.10 score on a scale
Standard Deviation 0.893
|
|
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
DAS28-ESR Week 48, change from week 24
|
0.00 score on a scale
Standard Deviation 1.025
|
-0.04 score on a scale
Standard Deviation 1.015
|
SECONDARY outcome
Timeframe: up to 48 weeksPopulation: Safety Set
Incidence of injection site reactions
Outcome measures
| Measure |
Humira / Switched GP2017
n=166 Participants
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).
|
GP2017
n=159 Participants
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).
|
|---|---|---|
|
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Number of patients with ISRs
|
2 Participants
|
1 Participants
|
|
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Injection site erythema
|
2 Participants
|
1 Participants
|
|
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Injection site pruritus
|
1 Participants
|
0 Participants
|
|
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
injection site reactions MILD
|
1 Participants
|
1 Participants
|
|
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
injection site reactions MODERATE
|
1 Participants
|
0 Participants
|
|
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
injection site reactions SEVERE
|
0 Participants
|
0 Participants
|
Adverse Events
Study Period 1 SP1 SAF GP2017
Serious events: 5 serious events
Other events: 83 other events
Deaths: 0 deaths
Study Period 1 SP1 SAF Humira
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
Study Period 2 SP2 SAF Continued GP2017
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Study Period 2 SP2 SAF Humira to GP2017
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Entire Study SP1 SAF GP2017
Serious events: 7 serious events
Other events: 94 other events
Deaths: 0 deaths
Entire Study SP1 SAF Humira/Switched GP2017
Serious events: 10 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Period 1 SP1 SAF GP2017
n=177 participants at risk
Study Period 1 SP1 SAF GP2017
|
Study Period 1 SP1 SAF Humira
n=176 participants at risk
Study Period 1 SP1 SAF Humira
|
Study Period 2 SP2 SAF Continued GP2017
n=159 participants at risk
Study Period 2 SP2 SAF Continued GP2017
|
Study Period 2 SP2 SAF Humira to GP2017
n=166 participants at risk
Study Period 2 SP2 SAF Humira to GP2017
|
Entire Study SP1 SAF GP2017
n=177 participants at risk
Entire study SP1 SAF GP2017
|
Entire Study SP1 SAF Humira/Switched GP2017
n=176 participants at risk
Entire study SP1 SAF Humira/Switched GP2017
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Hepatobiliary disorders
Hepatitis
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Infections and infestations
Bronchitis
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Infections and infestations
Pneumonia
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
1.2%
2/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
1.1%
2/176 • 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.
AE additional description
|
|
Infections and infestations
Pneumonia bacterial
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
Other adverse events
| Measure |
Study Period 1 SP1 SAF GP2017
n=177 participants at risk
Study Period 1 SP1 SAF GP2017
|
Study Period 1 SP1 SAF Humira
n=176 participants at risk
Study Period 1 SP1 SAF Humira
|
Study Period 2 SP2 SAF Continued GP2017
n=159 participants at risk
Study Period 2 SP2 SAF Continued GP2017
|
Study Period 2 SP2 SAF Humira to GP2017
n=166 participants at risk
Study Period 2 SP2 SAF Humira to GP2017
|
Entire Study SP1 SAF GP2017
n=177 participants at risk
Entire study SP1 SAF GP2017
|
Entire Study SP1 SAF Humira/Switched GP2017
n=176 participants at risk
Entire study SP1 SAF Humira/Switched GP2017
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
2/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.3%
4/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
3/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
4/177 • 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.
AE additional description
|
4.0%
7/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.3%
4/177 • 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.
AE additional description
|
4.0%
7/176 • 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.
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
2.8%
5/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
General disorders
Fatigue
|
2.8%
5/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
General disorders
Injection site erythema
|
1.1%
2/177 • 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.
AE additional description
|
3.4%
6/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
1.2%
2/166 • 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.
AE additional description
|
1.7%
3/177 • 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.
AE additional description
|
3.4%
6/176 • 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.
AE additional description
|
|
Infections and infestations
Bronchitis
|
2.3%
4/177 • 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.
AE additional description
|
4.5%
8/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
2.4%
4/166 • 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.
AE additional description
|
2.3%
4/177 • 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.
AE additional description
|
6.8%
12/176 • 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.
AE additional description
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/177 • 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.
AE additional description
|
2.3%
4/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
1.7%
3/177 • 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.
AE additional description
|
2.3%
4/176 • 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.
AE additional description
|
|
Infections and infestations
Influenza
|
1.7%
3/177 • 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.
AE additional description
|
2.8%
5/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.3%
4/177 • 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.
AE additional description
|
2.8%
5/176 • 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.
AE additional description
|
|
Infections and infestations
Oral herpes
|
2.3%
4/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
|
Infections and infestations
Pharyngitis
|
5.1%
9/177 • 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.
AE additional description
|
5.7%
10/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
1.8%
3/166 • 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.
AE additional description
|
5.6%
10/177 • 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.
AE additional description
|
5.7%
10/176 • 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.
AE additional description
|
|
Infections and infestations
Sinusitis
|
2.8%
5/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
1.2%
2/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
2.8%
5/176 • 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.
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
12/177 • 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.
AE additional description
|
4.0%
7/176 • 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.
AE additional description
|
2.5%
4/159 • 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.
AE additional description
|
1.8%
3/166 • 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.
AE additional description
|
7.9%
14/177 • 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.
AE additional description
|
5.1%
9/176 • 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.
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
2.3%
4/177 • 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.
AE additional description
|
3.4%
6/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
1.8%
3/166 • 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.
AE additional description
|
3.4%
6/177 • 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.
AE additional description
|
4.5%
8/176 • 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.
AE additional description
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.7%
26/177 • 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.
AE additional description
|
9.1%
16/176 • 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.
AE additional description
|
2.5%
4/159 • 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.
AE additional description
|
2.4%
4/166 • 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.
AE additional description
|
16.4%
29/177 • 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.
AE additional description
|
10.8%
19/176 • 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.
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
1.1%
2/177 • 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.
AE additional description
|
2.3%
4/176 • 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.
AE additional description
|
|
Investigations
Transaminases increased
|
0.00%
0/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
0.63%
1/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.56%
1/177 • 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.
AE additional description
|
2.3%
4/176 • 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.
AE additional description
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.7%
3/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
8/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
5.6%
10/177 • 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.
AE additional description
|
0.00%
0/176 • 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.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.7%
3/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
3.1%
5/159 • 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.
AE additional description
|
1.2%
2/166 • 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.
AE additional description
|
3.4%
6/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
|
Nervous system disorders
Headache
|
4.0%
7/177 • 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.
AE additional description
|
2.8%
5/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
1.2%
2/166 • 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.
AE additional description
|
4.5%
8/177 • 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.
AE additional description
|
4.0%
7/176 • 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.
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
1.9%
3/159 • 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.
AE additional description
|
0.00%
0/166 • 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.
AE additional description
|
2.8%
5/177 • 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.
AE additional description
|
0.57%
1/176 • 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.
AE additional description
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
0.00%
0/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
0.00%
0/177 • 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.
AE additional description
|
2.3%
4/176 • 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.
AE additional description
|
|
Vascular disorders
Hypertension
|
2.8%
5/177 • 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.
AE additional description
|
1.7%
3/176 • 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.
AE additional description
|
1.3%
2/159 • 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.
AE additional description
|
0.60%
1/166 • 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.
AE additional description
|
3.4%
6/177 • 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.
AE additional description
|
2.3%
4/176 • 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.
AE additional description
|
Additional Information
Sandoz Biopharma Clinical Development - Strategic Planning
Hexal AG/Sandoz Inc.
Phone: 0049(0)80244760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER