Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01147341
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : March 26, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Michael Schiff, MD, Schiff, Michael, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Cimzia
Drug: Placebo
Enrollment 37
Recruitment Details all patients recruited from US medical/Rheumatology clinics
Pre-assignment Details patients excluded from protocol if they did not meet entry criteria for active Rheumatoid arthritis
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description

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.

Reporting group: Placebo : prefilled saline syringe during the Double Blind Period

10 patients entered

Period Title: Double Blind Period
Started 27 10
Completed 26 8
Not Completed 1 2
Reason Not Completed
Lack of Efficacy             1             1
Withdrawal by Subject             0             1
Period Title: Open Label Period
Started 26 8
Completed 22 8
Not Completed 4 0
Reason Not Completed
Lack of Efficacy             3             0
Subject moved             1             0
Arm/Group Title Active Treatment With Cimzia Placebo Total
Hide Arm/Group Description

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Total of all reporting groups
Overall Number of Baseline Participants 27 10 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 10 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  85.2%
8
  80.0%
31
  83.8%
>=65 years
4
  14.8%
2
  20.0%
6
  16.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 10 participants 37 participants
Female
23
  85.2%
8
  80.0%
31
  83.8%
Male
4
  14.8%
2
  20.0%
6
  16.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 10 participants 37 participants
27 10 37
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 26 9
Measure Type: Number
Unit of Measure: participants
22 2
2.Primary Outcome
Title Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
Hide Description

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.

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 26 9
Measure Type: Number
Unit of Measure: participants
16 0
3.Secondary Outcome
Title 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
Hide Description

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.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 26 9
Measure Type: Number
Unit of Measure: participants
5 0
4.Secondary Outcome
Title 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)
Hide Description

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

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 26 9
Measure Type: Number
Unit of Measure: participants
6 0
5.Secondary Outcome
Title Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
Hide Description

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).

Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 26 9
Measure Type: Number
Unit of Measure: participants
17 0
6.Secondary Outcome
Title 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
Hide Description 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..
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 26 9
Measure Type: Number
Unit of Measure: participants
17 0
7.Other Pre-specified Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 22 8
Measure Type: Number
Unit of Measure: participants
18 6
8.Other Pre-specified Outcome
Title Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
Hide Description

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.

Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 22 8
Measure Type: Number
Unit of Measure: participants
12 5
9.Other Pre-specified Outcome
Title Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
Hide Description

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.

Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 22 8
Measure Type: Number
Unit of Measure: participants
6 3
10.Other Pre-specified Outcome
Title 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)
Hide Description

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

Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 22 8
Measure Type: Number
Unit of Measure: participants
7 3
11.Other Pre-specified Outcome
Title Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
Hide Description

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).

Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 22 8
Measure Type: Number
Unit of Measure: participants
17 6
12.Other Pre-specified Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description:

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

Overall Number of Participants Analyzed 22 8
Measure Type: Number
Unit of Measure: participants
16 5
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Active Treatment With Cimzia Placebo
Hide Arm/Group Description

Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks

27 patients entered

Placebo : prefilled saline syringe

10 patients entered

All-Cause Mortality
Active Treatment With Cimzia Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Active Treatment With Cimzia Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/34 (2.94%)      0/10 (0.00%)    
Gastrointestinal disorders     
gastric ulcer bleed  1 [1]  1/34 (2.94%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Subject hospitalized after the last visit of the protocol but prior to the 30 day follow-up phone call.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Treatment With Cimzia Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/34 (79.41%)      8/10 (80.00%)    
Cardiac disorders     
hypertension * 1  1/34 (2.94%)  1 1/10 (10.00%)  1
coronary disease * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Eye disorders     
conjunctival hemorrhage * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
constipation * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
nausea * 1  2/34 (5.88%)  2 0/10 (0.00%)  0
gastroesophageal reflux disease * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
vomiting * 1  1/34 (2.94%)  1 1/10 (10.00%)  1
gastrointestinal virus * 1  2/34 (5.88%)  2 0/10 (0.00%)  0
abdominal pain * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
General disorders     
head congestion * 1  1/34 (2.94%)  1 1/10 (10.00%)  1
hot face * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
allergies * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
fall * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Infections and infestations     
upper respiratory infections  1  5/27 (18.52%)  5 0/10 (0.00%)  0
cough * 1  3/34 (8.82%)  3 1/10 (10.00%)  1
tooth abcess * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
cold sore * 1  2/34 (5.88%)  2 0/10 (0.00%)  0
sinus infection * 1  2/34 (5.88%)  2 0/10 (0.00%)  0
urinary tract infection * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
fever * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
spider bite * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
sore throat * 1  1/34 (2.94%)  1 1/10 (10.00%)  1
bronchitis * 1  3/34 (8.82%)  3 0/10 (0.00%)  0
viral cold * 1  2/34 (5.88%)  2 0/10 (0.00%)  0
athletes foot * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
mouth sores * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
oral thrush * 1  1/34 (2.94%)  1 1/10 (10.00%)  1
sinusitis * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
shingles * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
sinus congestion * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
rhinorrhea * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
chest congestion * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
neck pain * 1  1/34 (2.94%)  1 1/10 (10.00%)  1
increased knee pain * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
back strain * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
heel pain * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
shoulder sprain * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
muscle tenderness * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
hand pain * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
bruised tailbone * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
swollen elbow * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
rheumatoid arthritis flare * 1  0/34 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders     
headache * 1  2/34 (5.88%)  2 0/10 (0.00%)  0
Psychiatric disorders     
anxiety * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
kidney stone * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
hematuria * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
emphysema * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders     
rash * 1  4/34 (11.76%)  4 0/10 (0.00%)  0
third degree burn * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
actenic keratosis * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
acne * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
injection site reaction * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
contact dermatitis * 1  1/34 (2.94%)  1 0/10 (0.00%)  0
bug bites * 1  0/34 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael schiff
Organization: michael schiff
Phone: 303 773 8429
EMail: michael.schiff@me.com
Layout table for additonal information
Responsible Party: Michael Schiff, MD, Schiff, Michael, M.D.
ClinicalTrials.gov Identifier: NCT01147341    
Other Study ID Numbers: CERT-001
First Submitted: June 17, 2010
First Posted: June 22, 2010
Results First Submitted: February 3, 2014
Results First Posted: March 26, 2014
Last Update Posted: June 9, 2014