Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents

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: NCT01691014
Recruitment Status : Terminated (The study was terminated on 10DEC2014 due to the inability to enroll the planned number of patients. There were no safety concerns.)
First Posted : September 24, 2012
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis (RA)
Intervention Other: non-interventional study
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Period Title: Overall Study
Started 8 26 36 9
Completed 5 11 25 4
Not Completed 3 15 11 5
Reason Not Completed
Premature Termination             1             6             0             3
Other             0             0             2             0
Withdrawal by Subject             0             1             1             1
Adverse Event             0             5             1             1
Lack of Efficacy             2             3             7             0
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab Total
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. Total of all reporting groups
Overall Number of Baseline Participants 8 26 36 9 79
Hide Baseline Analysis Population Description
Effectiveness analysis set (EAS) included all participants that provided at least 1 post-baseline assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 26 participants 36 participants 9 participants 79 participants
51  (6) 57  (13) 56  (14) 51  (11) 55  (13)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 26 participants 36 participants 9 participants 79 participants
Female
4
  50.0%
21
  80.8%
23
  63.9%
6
  66.7%
54
  68.4%
Male
4
  50.0%
5
  19.2%
13
  36.1%
3
  33.3%
25
  31.6%
1.Primary Outcome
Title Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
Hide Description Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
Hide Description Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment
Hide Description Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.
Time Frame Month 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment
Hide Description Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
Time Frame Month 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits
Hide Description Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.
Time Frame Month 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
Hide Description Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Time Frame Month 3, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment
Hide Description Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12
Hide Description DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity.
Time Frame Month 3, 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
EAS included all participants that provided at least 1 post-baseline assessment. Here,"n" signifies number of participants evaluable at the specified time points for this outcome measure.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 8 26 36 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (n= 7, 23, 34, 8) 3.2  (1.0) 3.0  (1.1) 3.0  (1.4) 3.0  (2.0)
Month 6 (n= 6, 18, 26, 6) 2.7  (1.6) 2.2  (1.1) 2.4  (1.3) 1.8  (1.0)
Month 12 (n= 5, 11, 25, 4) 2.6  (0.8) 2.4  (0.8) 2.5  (1.1) 2.7  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.990
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.980
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
Hide Description HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
Time Frame Baseline, Month 3, 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
EAS included all participants that provided at least 1 post-baseline assessment. Here, "n" signifies number of participants evaluable for this outcome measure at the specified time points.
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
Overall Number of Participants Analyzed 8 26 36 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 8, 26, 36, 9) 1.1  (0.6) 1.2  (0.6) 1.2  (0.7) 1.1  (0.5)
Month 3 (n= 7, 23, 34, 8) 0.8  (0.6) 0.9  (0.7) 0.8  (0.7) 1.2  (0.8)
Month 6 (n= 6, 18, 26, 6) 0.8  (0.2) 0.6  (0.6) 0.7  (0.6) 0.8  (0.7)
Month 12 (n= 5, 11, 25, 4) 0.7  (0.4) 1.0  (0.8) 0.6  (0.6) 0.8  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.945
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.896
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adalimumab, Etanercept, Certolizumab, Infliximab
Comments HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.390
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Baseline upto 12 months
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participants may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Adalimumab Etanercept Certolizumab Infliximab
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
All-Cause Mortality
Adalimumab Etanercept Certolizumab Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Adalimumab Etanercept Certolizumab Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   2/26 (7.69%)   2/36 (5.56%)   0/9 (0.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Infections and infestations         
Infection * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Pyelonephritis * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Tuberculosis * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of esophagus * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Vascular disorders         
Vasculitis * 1  1/8 (12.50%)  0/26 (0.00%)  0/36 (0.00%)  0/9 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab Etanercept Certolizumab Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   13/26 (50.00%)   6/36 (16.67%)   6/9 (66.67%) 
Blood and lymphatic system disorders         
Thrombopenia * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Cardiac disorders         
Palpitations * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Gastrointestinal disorders         
Nausea * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  1/9 (11.11%) 
Periumbilical pain * 1  1/8 (12.50%)  0/26 (0.00%)  0/36 (0.00%)  0/9 (0.00%) 
General disorders         
Feeling unwell * 1  0/8 (0.00%)  0/26 (0.00%)  0/36 (0.00%)  1/9 (11.11%) 
Fever * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Injection site erythema * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Therapeutic product ineffective * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Polyp * 1  0/8 (0.00%)  0/26 (0.00%)  0/36 (0.00%)  1/9 (11.11%) 
Foreign body reaction * 1  1/8 (12.50%)  0/26 (0.00%)  0/36 (0.00%)  0/9 (0.00%) 
Immune system disorders         
Allergic reaction * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Allergy NOS * 1  0/8 (0.00%)  0/26 (0.00%)  0/36 (0.00%)  1/9 (11.11%) 
Infections and infestations         
Cold * 1  0/8 (0.00%)  0/26 (0.00%)  0/36 (0.00%)  1/9 (11.11%) 
Erysipelas * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Infection localised * 1  1/8 (12.50%)  0/26 (0.00%)  0/36 (0.00%)  0/9 (0.00%) 
Nose infection NOS * 1  1/8 (12.50%)  0/26 (0.00%)  0/36 (0.00%)  0/9 (0.00%) 
Pneumonia * 1  0/8 (0.00%)  2/26 (7.69%)  0/36 (0.00%)  0/9 (0.00%) 
Rhinitis * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Tonsillitis * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Urinary tract infection * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  2/9 (22.22%) 
Cold sores lip * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Flu symptoms * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Lung infection * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Injury, poisoning and procedural complications         
Wound * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Investigations         
Elevated liver enzymes * 1  0/8 (0.00%)  0/26 (0.00%)  1/36 (2.78%)  0/9 (0.00%) 
Liver function test abnormal * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Eczema aggravated * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Pruritus * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Rash * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Urticaria * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Palmoplantar pustulosis * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Drug rash * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Vascular disorders         
Aortic aneurysm * 1  0/8 (0.00%)  1/26 (3.85%)  0/36 (0.00%)  0/9 (0.00%) 
Hypertension arterial * 1  1/8 (12.50%)  0/26 (0.00%)  0/36 (0.00%)  0/9 (0.00%) 
Deep vein thrombosis leg * 1  0/8 (0.00%)  0/26 (0.00%)  0/36 (0.00%)  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Due to premature termination of the study, the primary objective and few of the secondary objectives for the study were not met.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer Inc.
Organization: Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc.
Phone: 001 800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01691014    
Other Study ID Numbers: B1801347
First Submitted: September 12, 2012
First Posted: September 24, 2012
Results First Submitted: November 1, 2016
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016