Lead Investigator: Vipul Jairath, Alimentiv
Title of Proposal Research: Correlation Between Symptoms and Objective Measures of Disease Activity in Patients with Moderate to Severe Ulcerative Colitis and Crohn’s Disease
Vivli Data Request: 8316
Funding Source: Alimentiv is providing funding in in the form of resources to conduct the anlaysis. Alimentiv is a contract research organization that uses the profits from delivery of commercial services to reinvest in academic research that aligns with its partners shared purpose to accelerate drug discovery.
Potential Conflicts of Interest: Dr. Jairath reports: Received consulting fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, GlaxoSmithKline, Genetech, Gilead, Janssen, Merck, Mylan, Pendopharm, Pfizer, Roche, Sandoz, Takeda, Topivert; speaker’s fees from, Abbvie, Ferring, Janssen Pfizer Shire, Takeda.
This research is internally funded by Alimentiv and it is not receiving funds from any pharmaceutical company listed above. The funding information will be disclosed in any subsequent publication.
Dr. Ma reports: Received consulting fees from AbbVie, Alimentiv Inc. (formerly Robarts Clinical Trials Inc.), Amgen, AVIR Pharma Inc, Ferring, Fresenius Kabi, Janssen, Mylan, Takeda, Pfizer, Roche; speaker’s fees from AbbVie, AVIR Pharma Inc, Janssen, Takeda, and Pfizer; research support from Pfizer.
This research is internally funded by Alimentiv and it is not receiving funds from any pharmaceutical company listed above. The funding information will be disclosed in any subsequent publication.
Dr. Hanzel reports: Received speaker’s fees from Abbvie, Janssen, Takeda; consulting fees from Alimentiv Inc.
Summary of the Proposed Research:
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) which carry a substantial burden on patients’ quality of life. Assessing disease activity in patients with IBD has traditionally included symptoms (or patient-reported outcomes [PROs]), visualization of the bowel mucosa at endoscopy, microscopic evaluation of inflammation (histology), and evaluating levels of biomarkers of inflammation in the blood (i.e., C-reactive protein [CRP] and stool (fecal calprotectin [FCP]). While symptom resolution is an important goal of therapy, the correlation between PROs and objective disease measures (i.e., endoscopy, histology, biomarkers) is poor.
Understanding the relationship between symptoms and endoscopic, histologic, and biomarker measures of disease is important for several reasons. First, clinical decisions such as treatment initiation or escalation are frequently made based on patient symptoms, although this may not be reflective of objective disease activity. Second, evaluating the efficacy of novel therapies in IBD clinical trials will rely on PROs. Third, understanding the relationship between symptoms and bowel healing will help inform decision-making by physicians, particularly during early treatment of IBD. Patients may have different preferences and consider medication attributes in addition to the likelihood of achieving remission, such as the speed of symptom improvement.
Individual patient data will help determine
1. the correlation between symptoms and objective measures of healing;
2. how effective different treatments are (treatment effect sizes) when assessed using different PROs and/or objective disease measures; and
3. the speed of symptom resolution and objective measures of bowel healing with treatment, and their relationship to one another.
Requested Studies:
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer
Study ID: NCT01465763
Sponsor ID: A3921094
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
Data Contributor: Pfizer
Study ID: NCT01458951
Sponsor ID: A3921095
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT00783718
Sponsor ID: C13006
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT02497469
Sponsor ID: MLN0002-3026
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Data Contributor: Takeda
Study ID: NCT02611830
Sponsor ID: MLN0002SC-3027
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT02407236
Sponsor ID: CR106920
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn’s Disease
Data Contributor: Takeda
Study ID: NCT00783692
Sponsor ID: C13007
Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn’s Disease Naive to Both Immunomodulators and Biologic Therapy
Data Contributor: Johnson & Johnson
Study ID: NCT00094458
Sponsor ID: CR004804
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn’s Disease Involving the Colon
Data Contributor: AbbVie
Study ID: NCT00348283
Sponsor ID: M05-769
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
Data Contributor: Johnson & Johnson
Study ID: NCT01369329
Sponsor ID: CR018415
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease (UNITI-2)
Data Contributor: Johnson & Johnson
Study ID: NCT01369342
Sponsor ID: CR018418
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease
Data Contributor: Johnson & Johnson
Study ID: NCT01369355
Sponsor ID: CR018421