Crohn's DiseasePhase 3GEMINI IIINCT01224171
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
A Phase 3 study testing vedolizumab in people with Crohn's Disease, run by Millennium Pharmaceuticals, Inc. at 41 sites in 2 countries.
Trial summary
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- Crohn's Disease involvement of the ileum and/or colon
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Who cannot join
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- History of >3 small bowel resections or diagnosis of short bowel syndrome
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
- Active or latent tuberculosis
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States40 sites
University of Michigan
Ann Arbor, Michigan, 48109
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Gastroenterology Associates
Baton Rouge, Louisiana, 70809
Massachusetts General Hospital Crohn's and Colitis Center
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Charlotte Gastroenterology and Hepatology P.L.L.C
Charlotte, North Carolina, 28207
University of Virginia Health System
Charlottesville, Virginia, 22908
Metropolitan Gastroenterology Group P.C.
Chevy Chase, Maryland, 20815
University of Chicago Medical Center
Chicago, Illinois, 60637
Consultants for Clinical Research Inc.
Cincinnati, Ohio, 45219
Consultants in Gastroenterology
Columbia, South Carolina, 29203
University of Florida
Gainesville, Florida, 32610
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, 38138
Long Island Clinical Research Associates
Great Neck, New York, 11021
Gastroenterology Center of Connecticut P.C.
Hamden, Connecticut, 65180
Gastroenterology Research of New Orleans
Hammond, Louisiana, 70403
Mid-Atlantic Medical Research Center
Hollywood, Maryland, 20636
Gastroenterology of the Rockies
Lafayette, Colorado, 80026
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Medical Center
Lexington, Kentucky, 40536
University Of Louisville
Louisville, Kentucky, 40402
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
University of Miami Miller School of Medicine
Miami, Florida, 33136
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
New York Presbyterian Hospital
New York, New York, 10021
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, 55446
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229
University of Washington School of Medicine
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
Atlanta Gastroenterology Specialist PC
Suwanee, Georgia, 30024
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606
Center for Digestive Health
Troy, Michigan, 48098
Options Health Research
Tulsa, Oklahoma, 74104
Digestive Health Specialists of Tyler
Tyler, Texas, 75701
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197
Canada1 site
Zeidler Ledcor Center-Univerisity of Alberta
Edmonton, Alberta, T6G2X8
About this study
Official title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Read the detailed description
After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.
Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.
- Conditions
- Crohn's Disease
- Being tested
- vedolizumab, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vedolizumabDrug
Also called Entyvio, MLN0002, MLN02, LDP-02
Vedolizumab for intravenous infusion
PlaceboOther
Placebo intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo intravenous infusion at Weeks 0, 2 and 6. Receives: Other: Placebo |
| Vedolizumab | Experimental | Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. Receives: Drug: vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Measured: Week 6
Secondary outcomes (7)
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Measured: Week 6
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Measured: Week 10
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Measured: Week 10
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Measured: Week 6 and Week 10
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Measured: Week 6 and Week 10
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percent deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Measured: Baseline and Week 6
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).
Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?
Measured: From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224171
- Sponsor's protocol ID
- C13011
- Other IDs
- U1111-1158-2581, 2009-016488-12, NL34356.078.10, 2009
- Acronym
- GEMINI III
- Status last verified
- Jun 2014
- First submitted
- 18 Oct 2010
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sands BE, Van Assche G, Tudor D, Akhundova-Unadkat G, Curtis RI, Tan T. Vedolizumab in Combination With Corticosteroids for Induction Therapy in Crohn's Disease: A Post Hoc Analysis of GEMINI 2 and 3. Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382. doi: 10.1093/ibd/izy384.
PubMed 30615117Feagan BG, Sandborn WJ, Colombel JF, Byrne SO, Khalid JM, Kempf C, Geransar P, Bhayat F, Rubin DT. Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials. J Crohns Colitis. 2019 Jan 1;13(1):50-57. doi: 10.1093/ecco-jcc/jjy125.
PubMed 30203005Feagan BG, Lasch K, Lissoos T, Cao C, Wojtowicz AM, Khalid JM, Colombel JF. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7. doi: 10.1016/j.cgh.2018.05.026. Epub 2018 May 29.
PubMed 29857145Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
PubMed 26893500Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
PubMed 25996351Sands BE, Feagan BG, Rutgeerts P, Colombel JF, Sandborn WJ, Sy R, D'Haens G, Ben-Horin S, Xu J, Rosario M, Fox I, Parikh A, Milch C, Hanauer S. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21.
PubMed 24859203
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01224171
- Acronym / sponsor ID
- GEMINI III / C13011
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Detailed description
After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.
Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants received placebo intravenous infusion at Weeks 0, 2 and 6. |
| Vedolizumab | Experimental | Drug: vedolizumabParticipants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- Crohn's Disease involvement of the ileum and/or colon
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Key exclusion criteria (7 listed)
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- History of >3 small bowel resections or diagnosis of short bowel syndrome
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vedolizumabAlso: Entyvio, MLN0002, MLN02, LDP-02Vedolizumab for intravenous infusion | Drug | Vedolizumab |
| PlaceboPlacebo intravenous infusion | Other | Placebo |
Primary outcome
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Time frame: Week 6
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of < 0.47 in men and < 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
7 secondary outcomes
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Time frame: Week 6
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
Time frame: Week 10
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
Time frame: Week 10
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Time frame: Week 6 and Week 10
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Time frame: Week 6 and Week 10
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Time frame: Baseline and Week 6
Number of Participants With Adverse Events (AEs)
Time frame: From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30615117Sands BE, Van Assche G, Tudor D, Akhundova-Unadkat G, Curtis RI, Tan T. Vedolizumab in Combination With Corticosteroids for Induction Therapy in Crohn's Disease: A Post Hoc Analysis of GEMINI 2 and 3. Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382. doi: 10.1093/ibd/izy384.
- Derived from this study: PubMed 30203005Feagan BG, Sandborn WJ, Colombel JF, Byrne SO, Khalid JM, Kempf C, Geransar P, Bhayat F, Rubin DT. Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials. J Crohns Colitis. 2019 Jan 1;13(1):50-57. doi: 10.1093/ecco-jcc/jjy125.
- Derived from this study: PubMed 29857145Feagan BG, Lasch K, Lissoos T, Cao C, Wojtowicz AM, Khalid JM, Colombel JF. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7. doi: 10.1016/j.cgh.2018.05.026. Epub 2018 May 29.
- Derived from this study: PubMed 26893500Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
- Derived from this study: PubMed 25996351Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
- Derived from this study: PubMed 24859203Sands BE, Feagan BG, Rutgeerts P, Colombel JF, Sandborn WJ, Sy R, D'Haens G, Ben-Horin S, Xu J, Rosario M, Fox I, Parikh A, Milch C, Hanauer S. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vedolizumab in people with Crohn's Disease, run by Millennium Pharmaceuticals, Inc. at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224171, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.