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Trial record 1 of 1 for:    NCT01345318
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B0151005 Open-Label Extension Study (ANDANTE II)

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ClinicalTrials.gov Identifier: NCT01345318
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: PF-04236921
Enrollment 191
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-04236921
Hide Arm/Group Description All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
Period Title: Overall Study
Started 191
Completed 111
Not Completed 80
Reason Not Completed
Adverse Event             16
Lack of Efficacy             17
Lost to Follow-up             2
Protocol Violation             1
Withdrawal by Subject             41
Other             3
Arm/Group Title PF-04236921
Hide Arm/Group Description All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
Overall Number of Baseline Participants 191
Hide Baseline Analysis Population Description
Included all participants who received at least 1 dose of study treatment during the study B0151005
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants
40.1  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants
FEMALE
108
  56.5%
MALE
83
  43.5%
1.Primary Outcome
Title Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Hide Description An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.
Arm/Group Title PF-04236921
Hide Arm/Group Description:
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: participants
Participants with AEs 171
Participants with SAEs 58
Participants discontinued due to AEs 54
2.Primary Outcome
Title Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Hide Description Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.
Time Frame At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.
Arm/Group Title PF-04236921
Hide Arm/Group Description:
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: percentage of participants
ADA positive 0.52
NAbs positive 0.52
Time Frame [Not Specified]
Adverse Event Reporting Description The same event might have appeared 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 participant might have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-04236921
Hide Arm/Group Description All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
All-Cause Mortality
PF-04236921
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-04236921
Affected / at Risk (%)
Total   79/191 (41.36%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/191 (0.52%) 
Eye disorders   
Ulcerative keratitis * 1  1/191 (0.52%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/191 (0.52%) 
Abdominal pain lower * 1  1/191 (0.52%) 
Anal fistula * 1  4/191 (2.09%) 
Anorectal disorder * 1  1/191 (0.52%) 
Constipation * 1  1/191 (0.52%) 
Crohn's disease * 1  41/191 (21.47%) 
Dyspepsia * 1  1/191 (0.52%) 
Enterovesical fistula * 1  1/191 (0.52%) 
Fistula of small intestine * 1  2/191 (1.05%) 
Gastritis erosive * 1  1/191 (0.52%) 
Ileus * 1  1/191 (0.52%) 
Intestinal obstruction * 1  1/191 (0.52%) 
Large intestine perforation * 1  1/191 (0.52%) 
Pancreatitis acute * 1  1/191 (0.52%) 
Rectal haemorrhage * 1  2/191 (1.05%) 
Small intestinal obstruction * 1  2/191 (1.05%) 
Small intestinal perforation * 1  3/191 (1.57%) 
Vomiting * 1  1/191 (0.52%) 
Hepatobiliary disorders   
Cholangitis sclerosing * 1  1/191 (0.52%) 
Cholecystitis * 1  2/191 (1.05%) 
Cholecystitis chronic * 1  1/191 (0.52%) 
Hepatic function abnormal * 1  1/191 (0.52%) 
Infections and infestations   
Abdominal abscess * 1  4/191 (2.09%) 
Abscess * 1  1/191 (0.52%) 
Anal abscess * 1  1/191 (0.52%) 
Bartholin's abscess * 1 [1]  1/108 (0.93%) 
Cellulitis * 1  1/191 (0.52%) 
Cytomegalovirus infection * 1  2/191 (1.05%) 
Gastroenteritis * 1  1/191 (0.52%) 
Groin abscess * 1  1/191 (0.52%) 
Infectious colitis * 1  1/191 (0.52%) 
Latent tuberculosis * 1  1/191 (0.52%) 
Mesenteric abscess * 1  1/191 (0.52%) 
Perirectal abscess * 1  1/191 (0.52%) 
Peritonitis * 1  1/191 (0.52%) 
Peritonsillar abscess * 1  1/191 (0.52%) 
Pneumonia * 1  2/191 (1.05%) 
Rectal abscess * 1  1/191 (0.52%) 
Retroperitoneal abscess * 1  1/191 (0.52%) 
Sepsis * 1  1/191 (0.52%) 
Septic shock * 1  1/191 (0.52%) 
Subcutaneous abscess * 1  1/191 (0.52%) 
Tonsillitis * 1  2/191 (1.05%) 
Tooth abscess * 1  1/191 (0.52%) 
Tuberculosis * 1  1/191 (0.52%) 
Viral infection * 1  1/191 (0.52%) 
Viral upper respiratory tract infection * 1  1/191 (0.52%) 
Injury, poisoning and procedural complications   
Anastomotic fistula * 1  1/191 (0.52%) 
Concussion * 1  1/191 (0.52%) 
Fall * 1  1/191 (0.52%) 
Gastrointestinal anastomotic leak * 1  1/191 (0.52%) 
Intestinal anastomosis complication * 1  1/191 (0.52%) 
Lower limb fracture * 1  1/191 (0.52%) 
Post procedural haemorrhage * 1  1/191 (0.52%) 
Procedural complication * 1  1/191 (0.52%) 
Investigations   
Weight decreased * 1  1/191 (0.52%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/191 (1.05%) 
Musculoskeletal and connective tissue disorders   
Arthritis * 1  1/191 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Oncocytoma * 1  1/191 (0.52%) 
Nervous system disorders   
Multiple sclerosis relapse * 1  1/191 (0.52%) 
Pregnancy, puerperium and perinatal conditions   
Abortion missed * 1 [1]  1/108 (0.93%) 
Renal and urinary disorders   
Calculus ureteric * 1  1/191 (0.52%) 
Nephrolithiasis * 1  2/191 (1.05%) 
Renal colic * 1  1/191 (0.52%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/191 (0.52%) 
Chronic obstructive pulmonary disease * 1  1/191 (0.52%) 
Pneumothorax * 1  1/191 (0.52%) 
Vascular disorders   
Hypertension * 1  1/191 (0.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
[1]
Percentages of gender specific events are calculated using the corresponding gender count as denominator.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-04236921
Affected / at Risk (%)
Total   150/191 (78.53%) 
Blood and lymphatic system disorders   
Anaemia * 1  15/191 (7.85%) 
Gastrointestinal disorders   
Abdominal pain * 1  39/191 (20.42%) 
Crohn's disease * 1  45/191 (23.56%) 
Diarrhoea * 1  20/191 (10.47%) 
Nausea * 1  21/191 (10.99%) 
Vomiting * 1  22/191 (11.52%) 
General disorders   
Pyrexia * 1  14/191 (7.33%) 
Infections and infestations   
Bronchitis * 1  12/191 (6.28%) 
Gastroenteritis * 1  11/191 (5.76%) 
Nasopharyngitis * 1  31/191 (16.23%) 
Upper respiratory tract infection * 1  11/191 (5.76%) 
Urinary tract infection * 1  16/191 (8.38%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  23/191 (12.04%) 
Back pain * 1  12/191 (6.28%) 
Nervous system disorders   
Headache * 1  23/191 (12.04%) 
Psychiatric disorders   
Anxiety * 1  10/191 (5.24%) 
Insomnia * 1  11/191 (5.76%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  13/191 (6.81%) 
Skin and subcutaneous tissue disorders   
Erythema * 1  14/191 (7.33%) 
Rash * 1  18/191 (9.42%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01345318     History of Changes
Other Study ID Numbers: B0151005
2011-000722-30 ( EudraCT Number )
ANDANTE II ( Other Identifier: Alias Study Number )
First Submitted: April 28, 2011
First Posted: May 2, 2011
Results First Submitted: January 30, 2017
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017