Trial Outcomes & Findings for Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia (NCT NCT01147341)
NCT ID: NCT01147341
Last Updated: 2014-06-09
Results Overview
The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22. A CDAI reduction of 6.5 represents moderate improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2014-06-09
Participant Flow
all patients recruited from US medical/Rheumatology clinics
patients excluded from protocol if they did not meet entry criteria for active Rheumatoid arthritis
Participant milestones
| Measure |
Active Treatment With Cimzia
Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.
Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.
27 patients entered the Double Blind Portion.
|
Placebo
Reporting group: Placebo : prefilled saline syringe during the Double Blind Period
10 patients entered
|
|---|---|---|
|
Double Blind Period
STARTED
|
27
|
10
|
|
Double Blind Period
COMPLETED
|
26
|
8
|
|
Double Blind Period
NOT COMPLETED
|
1
|
2
|
|
Open Label Period
STARTED
|
26
|
8
|
|
Open Label Period
COMPLETED
|
22
|
8
|
|
Open Label Period
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Active Treatment With Cimzia
Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.
Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.
27 patients entered the Double Blind Portion.
|
Placebo
Reporting group: Placebo : prefilled saline syringe during the Double Blind Period
10 patients entered
|
|---|---|---|
|
Double Blind Period
Lack of Efficacy
|
1
|
1
|
|
Double Blind Period
Withdrawal by Subject
|
0
|
1
|
|
Open Label Period
Lack of Efficacy
|
3
|
0
|
|
Open Label Period
Subject moved
|
1
|
0
|
Baseline Characteristics
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Baseline characteristics by cohort
| Measure |
Active Treatment With Cimzia
n=27 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=10 Participants
Placebo : prefilled saline syringe
10 patients entered
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
10 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: 35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing
The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22. A CDAI reduction of 6.5 represents moderate improvement.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=26 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=9 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12
|
22 participants
|
2 participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: 35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing. 30 subjects who completed the 24 week study were included in the efficacy assessment at week 24.
ACR20 responders are subjects with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale(VAS). HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=26 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=9 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
|
16 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing
ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=26 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=9 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12
|
5 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing.
The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity. Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22
Outcome measures
| Measure |
Active Treatment With Cimzia
n=26 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=9 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)
|
6 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to week 12The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score. The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= \> 5.1, low disease activity= \< 3.2, and remission= \< 2.6. Clinically significant response= decrease of \>1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: \>5.1 or \<0.6 change from baseline).
Outcome measures
| Measure |
Active Treatment With Cimzia
n=26 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=9 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
|
17 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to week 12The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22. A CDAI reduction of 6.5 represents moderate improvement..
Outcome measures
| Measure |
Active Treatment With Cimzia
n=26 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=9 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12
|
17 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: 30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22. A CDAI reduction of 6.5 represents moderate improvement.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=22 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=8 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving a CDAI Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 24
|
18 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: 30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
ACR20 responders are subjects with at least 20% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=22 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=8 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
|
12 participants
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: 30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=22 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=8 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
|
6 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: 30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity. Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22
Outcome measures
| Measure |
Active Treatment With Cimzia
n=22 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=8 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)
|
7 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: 30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score. The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= \> 5.1, low disease activity= \< 3.2, and remission= \< 2.6. Clinically significant response= decrease of \>1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: \>5.1 or \<0.6 change from baseline).
Outcome measures
| Measure |
Active Treatment With Cimzia
n=22 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=8 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
|
17 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 24Population: 30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22. A CDAI reduction of 6.5 represents moderate improvement.
Outcome measures
| Measure |
Active Treatment With Cimzia
n=22 Participants
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=8 Participants
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 24
|
16 participants
|
5 participants
|
Adverse Events
Active Treatment With Cimzia
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Treatment With Cimzia
n=34 participants at risk
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=10 participants at risk
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Gastrointestinal disorders
gastric ulcer bleed
|
2.9%
1/34 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
Other adverse events
| Measure |
Active Treatment With Cimzia
n=34 participants at risk
Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered
|
Placebo
n=10 participants at risk
Placebo : prefilled saline syringe
10 patients entered
|
|---|---|---|
|
Infections and infestations
upper respiratory infections
|
18.5%
5/27 • Number of events 5 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
cough
|
8.8%
3/34 • Number of events 3 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
tooth abcess
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
cold sore
|
5.9%
2/34 • Number of events 2 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
General disorders
head congestion
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
sinus infection
|
5.9%
2/34 • Number of events 2 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Gastrointestinal disorders
constipation
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
urinary tract infection
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
fever
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
spider bite
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
sore throat
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
bronchitis
|
8.8%
3/34 • Number of events 3 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
viral cold
|
5.9%
2/34 • Number of events 2 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
athletes foot
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
rash
|
11.8%
4/34 • Number of events 4 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Nervous system disorders
headache
|
5.9%
2/34 • Number of events 2 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
mouth sores
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
third degree burn
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
actenic keratosis
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Psychiatric disorders
anxiety
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
emphysema
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Gastrointestinal disorders
nausea
|
5.9%
2/34 • Number of events 2 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Gastrointestinal disorders
vomiting
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
oral thrush
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Cardiac disorders
hypertension
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
General disorders
hot face
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
increased knee pain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
sinusitis
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
back strain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
shingles
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
heel pain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Gastrointestinal disorders
gastrointestinal virus
|
5.9%
2/34 • Number of events 2 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
General disorders
allergies
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
acne
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
sinus congestion
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
rhinorrhea
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Eye disorders
conjunctival hemorrhage
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
shoulder sprain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
muscle tenderness
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Cardiac disorders
coronary disease
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Renal and urinary disorders
kidney stone
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Renal and urinary disorders
hematuria
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
hand pain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Gastrointestinal disorders
abdominal pain
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
bruised tailbone
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
General disorders
fall
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
swollen elbow
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Musculoskeletal and connective tissue disorders
rheumatoid arthritis flare
|
0.00%
0/34 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Infections and infestations
chest congestion
|
2.9%
1/34 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
|
Skin and subcutaneous tissue disorders
bug bites
|
0.00%
0/34 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from the time informed consent was signed through the whole study period of 24 weeks. In addition, serious adverse events were collected up to 4 weeks after completion/discontinuation of the study.
As refer to the Safety Set which included all subjects who received at least 1 dose of study medication. Active treatment with Cimzia included those subjects in the double-blind portion of the protocol as well as the open label portion of the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60