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Efficacy and Safety Study of Ozanimod in Ulcerative Colitis (Touchstone)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ozanimod
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ulcerative colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

  • Current use of anti-TNF agents

Sites / Locations

  • Anaheim Clinical Trials
  • University of California San Diego
  • Alliance Clinical Research
  • Atlanta Gastroenterology Associates, LLC
  • Chevy Chase Clinical Research
  • Endoscopic Microsurgery Associates
  • Clinical Research Institute of Michigan, LLC
  • Long Island Clinical Research Associates
  • University of North Carolina
  • Consultants for Clinical Research
  • The Alfred Hospital
  • Universitair Ziekenhuis Leuven, Campus Gasthuisberg
  • Multiprofile Hospital for Active Treatment Kaspela
  • University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
  • UMHAT Sv Ivan Rilski EAD
  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
  • Military Medical Academy
  • Multiprofile Hospital for Active Treatment Doverie AD
  • Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD
  • Multiprofile Hospital for Active Treatment Sofiamed
  • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • London Health Sciences Centre, University Hospital
  • Evaggelismos General Hospital
  • University Hospital of Ioannina
  • University Hospital of Larissa
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Pannonia Maganorvosi Centrum
  • Uzsoki Utcai Korhaz
  • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
  • Barzilai Medical Center
  • Carmel Medical Center
  • Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital
  • Meir Medical Center
  • Yeungnam University Medical Center
  • Konyang University Hospital
  • Asan Medical Center
  • Kangbuk Samsung Medical Center
  • Severance Hospital, Yonsei University Health System
  • Kyunghee University Medical Center
  • Ewha Womans University Mokdong Hospital
  • The Catholic University of Korea, St.Vicent's Hospital
  • Wonju Christian Hospital
  • Academisch Medisch Centrum
  • Albert Schweitzer Ziekenhuis
  • Ikazia Ziekenhuis
  • Christchurch Hospital
  • Dunedin Hospital
  • Waikato Hospital
  • Hutt Valley District Health Board
  • North Shore Hospital
  • SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
  • Niepubliczny Zaklad Opieki Zdrowotnej INTERMED
  • Elblaski Szpital Specjalistyczny z Przychodnia
  • Przychodnia Lekarska Nowy Chelm
  • Economicus - NZOZ ALL-MEDICUS
  • Centrum Opieki Zdrowotnej Orkan Med
  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
  • Instytut Medycyny Wsi
  • MEDICOR Centrum Medyczne
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
  • Niepubliczny Zaklad Opieki Zdrowotnej Triclinium
  • LexMedica Osrodek Badan Klinicznych
  • Regional Clinical Hospital
  • SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF
  • Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
  • Novosibirsk State Medical University
  • SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
  • SEIHPE Rostov State Medical University of MoH of RF
  • Russian Medical Military Academy na SMKirov
  • City Hospital 26
  • Medical Company Hepatolog
  • Slovak Research Center
  • Specializovana Nemocnica Svorada Zobor
  • GASTRO I., s.r.o.
  • Ivano-Frankivsk Regional Clinical Hospital
  • Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
  • Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine
  • Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
  • Order of the Red Star MMMCC MMCH Clinic of Gastroenterology
  • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
  • Lviv Regional Clinical Hospital
  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • Vinnytsia Regional Clinical
  • Medical Clinical Research Center "Health Clinic"
  • Municipal Institution Zaporizhzhia
  • Zaporizhzhya city multidisciplinary clinical hospital #9

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ozanimod 0.5 mg

Ozanimod 1 mg

Placebo

Arm Description

Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA) Clinical Remission was based on the 4-component Mayo definition.

Secondary Outcome Measures

Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Clinical Respone was based on the 4-component Mayo definition.
Change From Baseline in Mayo Score at Week 8
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)
Percentage of Participants With Mucosal Healing at Week 8
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading. The endoscopy scale: 0 = Normal or inactive disease = Mild disease (erythema, decreased vascular pattern, mild friability) = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) = Severe disease (spontaneous bleeding, ulceration)
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)
Percentage of Participants Who Achieved Clinical Response at Week 32
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)
Percentage of Participants With Mucosal Healing at Week 32
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading. The endoscopy scale: 0 = Normal or inactive disease = Mild disease (erythema, decreased vascular pattern, mild friability) = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) = Severe disease (spontaneous bleeding, ulceration)
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.

Full Information

First Posted
July 19, 2012
Last Updated
May 14, 2021
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01647516
Brief Title
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Acronym
Touchstone
Official Title
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 26, 2012 (Actual)
Primary Completion Date
March 10, 2015 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozanimod 0.5 mg
Arm Type
Experimental
Arm Description
Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Arm Title
Ozanimod 1 mg
Arm Type
Experimental
Arm Description
Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
Zeposia, RPC 1063
Intervention Description
Ozanimod capsules by mouth daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Description
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA) Clinical Remission was based on the 4-component Mayo definition.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Description
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Clinical Respone was based on the 4-component Mayo definition.
Time Frame
Week 8
Title
Change From Baseline in Mayo Score at Week 8
Description
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)
Time Frame
Baseline to Week 8
Title
Percentage of Participants With Mucosal Healing at Week 8
Description
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading. The endoscopy scale: 0 = Normal or inactive disease = Mild disease (erythema, decreased vascular pattern, mild friability) = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) = Severe disease (spontaneous bleeding, ulceration)
Time Frame
Week 8
Title
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Description
Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)
Time Frame
Week 32
Title
Percentage of Participants Who Achieved Clinical Response at Week 32
Description
Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. Stool Frequency Subscore (SFS) Rectal bleeding Subscore (RBS) Endoscopy Subscore Physician's Global Assessment (PGA)
Time Frame
Week 32
Title
Percentage of Participants With Mucosal Healing at Week 32
Description
Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading. The endoscopy scale: 0 = Normal or inactive disease = Mild disease (erythema, decreased vascular pattern, mild friability) = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) = Severe disease (spontaneous bleeding, ulceration)
Time Frame
Week 32
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
Description
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Time Frame
From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
Description
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Time Frame
From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
Title
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
Description
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
Time Frame
From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ulcerative colitis (UC) confirmed on endoscopy Moderately to severely active UC (Mayo score 6-12) Exclusion Criteria: Current use of anti-TNF agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AnnKatrin Petersen, MD
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Atlanta Gastroenterology Associates, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Endoscopic Microsurgery Associates
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
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Multiprofile Hospital for Active Treatment Kaspela
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Sv Ivan Rilski EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Doverie AD
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD
City
Sofia
ZIP/Postal Code
1712
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sofiamed
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sveta Marina EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Evaggelismos General Hospital
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45110
Country
Greece
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705717
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejon
ZIP/Postal Code
302718
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
ZIP/Postal Code
110746
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
130702
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St.Vicent's Hospital
City
Suwon
ZIP/Postal Code
442723
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
ZIP/Postal Code
220701
Country
Korea, Republic of
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Hutt Valley District Health Board
City
Lower Hutt
ZIP/Postal Code
5010
Country
New Zealand
Facility Name
North Shore Hospital
City
Milford
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
City
Bialystok
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej INTERMED
City
Czestochowa
ZIP/Postal Code
42-217
Country
Poland
Facility Name
Elblaski Szpital Specjalistyczny z Przychodnia
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Przychodnia Lekarska Nowy Chelm
City
Gdansk
ZIP/Postal Code
80-807
Country
Poland
Facility Name
Economicus - NZOZ ALL-MEDICUS
City
Katowice
ZIP/Postal Code
40-660
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan Med
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Instytut Medycyny Wsi
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
MEDICOR Centrum Medyczne
City
Rzeszow
ZIP/Postal Code
35-068
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Triclinium
City
Warszawa
ZIP/Postal Code
02-797
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Regional Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630084
Country
Russian Federation
Facility Name
SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
City
Omsk
ZIP/Postal Code
644043
Country
Russian Federation
Facility Name
SEIHPE Rostov State Medical University of MoH of RF
City
Rostov on Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Russian Medical Military Academy na SMKirov
City
Saint Petersburg
ZIP/Postal Code
191163
Country
Russian Federation
Facility Name
City Hospital 26
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Medical Company Hepatolog
City
Samara
ZIP/Postal Code
443000
Country
Russian Federation
Facility Name
Slovak Research Center
City
Ilava
ZIP/Postal Code
01901
Country
Slovakia
Facility Name
Specializovana Nemocnica Svorada Zobor
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
GASTRO I., s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
City
Kyiv
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
Order of the Red Star MMMCC MMCH Clinic of Gastroenterology
City
Kyiv
ZIP/Postal Code
1133
Country
Ukraine
Facility Name
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
City
Kyiv
ZIP/Postal Code
2232
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Medical Clinical Research Center "Health Clinic"
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Zaporizhzhya city multidisciplinary clinical hospital #9
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27144850
Citation
Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, Ghosh S, Smith H, Cravets M, Frohna PA, Aranda R, Gujrathi S, Olson A; TOUCHSTONE Study Group. Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. N Engl J Med. 2016 May 5;374(18):1754-62. doi: 10.1056/NEJMoa1513248.
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Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

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