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A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
MultiStem low dose
placebo
MultiStem low dose
placebo
MultiStem high dose
placebo
MultiStem high dose
placebo
MultiStem high dose
placebo
MultiStem high dose
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring safety efficacy MultiStem(r) moderate to severe Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening.
  • Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.
  • Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing.
  • Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
  • Subjects must be on stable steroid doses.

Exclusion Criteria:

  • Subjects who have abnormal organ and marrow function.
  • Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
  • Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit.
  • Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.

Sites / Locations

  • University of California San Francisco
  • USCF Endoscopy Unit at Mount Zion
  • Clinical Research of the Rockies
  • Rocky Mountain Gastroenterology Associates, LLC
  • Arapahoe Gastroenterology, PC
  • Metropolitan Gastroenterology Group, PC
  • Gastroenterology Consultants of Clearwater
  • West Coast Endoscopy Center
  • Clinical Research of West Florida, Inc.
  • Borland-Groover Clinic
  • Jacksonville Center for Endoscopy
  • Miami Research Associates
  • University of Chicago Medical Center
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • University of Louisville Healthcare Outpatient Center
  • University of Louisville Hospital
  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
  • Endoscopic Microsurgery Associates, PA
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health
  • Utica Surgery Center
  • Surgery Center of Columbia
  • Center for Digestive and Liver Diseases, Inc.
  • Present, Chapman, Steinlauf and Marion
  • Mount Sinai School of Medicine
  • Asher Kornbluth, MD PC
  • Charlotte Gastroenterology and Hepatology, PLLC
  • Wake Internal Medicine Consultants, Inc.
  • Wake Research Associates
  • Wake Forest University University Baptist Medical Center - Internal Medicine
  • Gastro One
  • Vanderbilt University Medical Center
  • Digestive and Liver Disease Specialists
  • Sentara Leigh Hospital
  • Sentara Norfolk General Hospital
  • McGuire DVAMC
  • University of Washington Medical Center
  • Hopital Erasme / Gastroenterology
  • Pfizer Clinical Research Unit
  • University of Alberta Hospital
  • Northern Alberta Clinical Trials and Research Center
  • Zeidler Ledcor Centre - University of Alberta
  • Maisonneuve-Rosemont Hospital
  • Agaplesion Markus Krankenhaus
  • Universitaetsklinikum Halle
  • Medizinische Hochschule Hannover
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
  • Pandy Kalman Megyei Korhaz, III. sz. Belosztaly-Gasztroenterologia
  • Karolina Korhaz Rendelointezet, Belgyogyaszat
  • Tolna Megyei Balassa Janos Korhaz / II. Belgyogyaszat
  • Azienda Ospedaliera Luigi Sacco
  • Azienda Ospedaliera di Padova
  • Policlinico Universitario Agostino Gemelli
  • Gastroenterologicke a hepatologicke oddelenie, V. interna klinika LFUK a UN Bratislava, Ruzinov
  • Gastroenterologicka ambulancia, GEA s.r.o.
  • Sahlgrenska Universitetssjukhuset Medicinkliniken
  • Karolinska Universitetssjukhuset, GastroCentrum Medicin
  • Akademiska sjukhuset, Mag tarmmottagningen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

The first 9 subjects will be recruited into Cohort 1 and will receive either placebo (n=3) or MultiStem low dose (n=6) as an intravenous infusion on Day 1. The first five patients enrolled constitute a subgroup of Cohort 1 and these patients will receive multiple doses, once every day for 7 days for 3 doses (Day 1 and Weeks 1 & 2).

This group will receive either placebo (n=3) or MultiStem high dose (n=6) as an intravenous infusion on Day 1. The subjects then receive the opposite dose of study medication at Week 8.

These subjects (total n=88 evaluable patients) will receive either Placebo or MultiStem (1:1 randomization) as an intravenous infusion on Day 1. In addition all subjects in Cohort 3 will receive a single infusion of either MultiStem or Placebo at Week 8, depending on their randomization schedule. A total of ~22 patients will receive an additional infusion of MultiStem, ~44 patients will receive the alternative blinded therapy to that which they received for Day 1 infusion, and ~22 patients will receive an additional infusion of placebo.

Outcomes

Primary Outcome Measures

Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence 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 dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)
Number of Treatment-Emergent AEs by Severity
The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.

Secondary Outcome Measures

Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Number of Participants With Laboratory Test Abnormalities
The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP <90 millimeters of mercury (mm Hg) and >=30 mm Hg increase/decrease from baseline, DBP <50 mm Hg and >=20 mm Hg increase/decrease from baseline, pulse rate <40 or >120 beats per minute (bpm),
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16
Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16
Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).
Percentage of Participants in Endoscopic Remission at Week 8
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.
Percentage of Participants in Clinical Remission at Week 8
Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16
Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.
Percentage of Participants With Endoscopic Response at Week 8
Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.
Percentage of Participants in Clinical Response at Week 8
Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Change From Baseline in Total Mayo Scores at Week 8
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment [PGA]), each graded from 0 to 3, with higher scores indicating more severe disease.
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.
Change From Baseline in Biopsy Histology Scores at Week 8
A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16
Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding [RB]), if any.

Full Information

First Posted
November 10, 2010
Last Updated
January 26, 2016
Sponsor
Pfizer
Collaborators
Athersys, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01240915
Brief Title
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Official Title
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Athersys, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
safety efficacy MultiStem(r) moderate to severe Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
The first 9 subjects will be recruited into Cohort 1 and will receive either placebo (n=3) or MultiStem low dose (n=6) as an intravenous infusion on Day 1. The first five patients enrolled constitute a subgroup of Cohort 1 and these patients will receive multiple doses, once every day for 7 days for 3 doses (Day 1 and Weeks 1 & 2).
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
This group will receive either placebo (n=3) or MultiStem high dose (n=6) as an intravenous infusion on Day 1. The subjects then receive the opposite dose of study medication at Week 8.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
These subjects (total n=88 evaluable patients) will receive either Placebo or MultiStem (1:1 randomization) as an intravenous infusion on Day 1. In addition all subjects in Cohort 3 will receive a single infusion of either MultiStem or Placebo at Week 8, depending on their randomization schedule. A total of ~22 patients will receive an additional infusion of MultiStem, ~44 patients will receive the alternative blinded therapy to that which they received for Day 1 infusion, and ~22 patients will receive an additional infusion of placebo.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
once every 7 days for 1- 3 doses
Intervention Type
Drug
Intervention Name(s)
MultiStem low dose
Intervention Description
1-3 doses
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose at week 8
Intervention Type
Drug
Intervention Name(s)
MultiStem low dose
Intervention Description
Single dose at week 8
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose Day 1
Intervention Type
Drug
Intervention Name(s)
MultiStem high dose
Intervention Description
Single dose Day 1
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose at week 8
Intervention Type
Drug
Intervention Name(s)
MultiStem high dose
Intervention Description
Single dose at week 8
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose Day 1
Intervention Type
Drug
Intervention Name(s)
MultiStem high dose
Intervention Description
Single dose Day 1
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose at week 8
Intervention Type
Drug
Intervention Name(s)
MultiStem high dose
Intervention Description
Single dose at week 8
Primary Outcome Measure Information:
Title
Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8
Description
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).
Time Frame
Baseline and Week 8
Title
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4
Description
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Time Frame
Baseline and Week 4
Title
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8
Description
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Time Frame
Baseline and Week 8
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence 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 dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time Frame
Baseline up to Week 52
Title
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)
Time Frame
Baseline up to Week 52
Title
Number of Treatment-Emergent AEs by Severity
Description
The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.
Time Frame
Baseline up to Week 52
Secondary Outcome Measure Information:
Title
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16
Description
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Time Frame
Baseline, Week 12, Week 16
Title
Number of Participants With Laboratory Test Abnormalities
Description
The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Description
Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP <90 millimeters of mercury (mm Hg) and >=30 mm Hg increase/decrease from baseline, DBP <50 mm Hg and >=20 mm Hg increase/decrease from baseline, pulse rate <40 or >120 beats per minute (bpm),
Time Frame
Baseline up to Week 52
Title
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16
Description
Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.
Time Frame
Baseline, Weeks 4, 8, 12 and 16
Title
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16
Description
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.
Time Frame
Baseline, Weeks 4, 8, 12 and 16
Title
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16
Description
Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).
Time Frame
Week 4, 8, 12 and 16
Title
Percentage of Participants in Endoscopic Remission at Week 8
Description
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.
Time Frame
Week 8
Title
Percentage of Participants in Clinical Remission at Week 8
Description
Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.
Time Frame
Week 8
Title
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16
Description
Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.
Time Frame
Baseline, Weeks 4, 8, 12 and 16
Title
Percentage of Participants With Endoscopic Response at Week 8
Description
Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.
Time Frame
Week 8
Title
Percentage of Participants in Clinical Response at Week 8
Description
Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Time Frame
Week 8
Title
Change From Baseline in Total Mayo Scores at Week 8
Description
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment [PGA]), each graded from 0 to 3, with higher scores indicating more severe disease.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16
Description
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.
Time Frame
Baseline, Weeks 4, 8, 12 and 16
Title
Change From Baseline in Biopsy Histology Scores at Week 8
Description
A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).
Time Frame
Baseline and Week 8
Title
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16
Description
Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding [RB]), if any.
Time Frame
Baseline and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening. Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score. Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing. Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab. Subjects must be on stable steroid doses. Exclusion Criteria: Subjects who have abnormal organ and marrow function. Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease. Subjects who meet Truelove-Witts criteria for severe ulcerative colitis. Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit. Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
USCF Endoscopy Unit at Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Clinical Research of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates, LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Arapahoe Gastroenterology, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Gastroenterology Consultants of Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
West Coast Endoscopy Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Jacksonville Center for Endoscopy
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Louisville Healthcare Outpatient Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Endoscopic Microsurgery Associates, PA
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Utica Surgery Center
City
Utica
State/Province
Michigan
ZIP/Postal Code
48317
Country
United States
Facility Name
Surgery Center of Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Center for Digestive and Liver Diseases, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Present, Chapman, Steinlauf and Marion
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Asher Kornbluth, MD PC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Forest University University Baptist Medical Center - Internal Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-1375
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Sentara Leigh Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Hopital Erasme / Gastroenterology
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Clinical Research Unit
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Northern Alberta Clinical Trials and Research Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Zeidler Ledcor Centre - University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitaetsklinikum Halle
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pandy Kalman Megyei Korhaz, III. sz. Belosztaly-Gasztroenterologia
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Karolina Korhaz Rendelointezet, Belgyogyaszat
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Tolna Megyei Balassa Janos Korhaz / II. Belgyogyaszat
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Azienda Ospedaliera Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Gastroenterologicke a hepatologicke oddelenie, V. interna klinika LFUK a UN Bratislava, Ruzinov
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Gastroenterologicka ambulancia, GEA s.r.o.
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Facility Name
Sahlgrenska Universitetssjukhuset Medicinkliniken
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, GastroCentrum Medicin
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Akademiska sjukhuset, Mag tarmmottagningen
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3041001&StudyName=A%20Study%20To%20Investigate%20The%20Safety%20And%20Possible%20Clinical%20Benefit%20Of%20Multistem%28r%29%20In%20Patients%20With%20Moderate%20To%20Severe%20Ulcerative%20Colit
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

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