IBD Clinical Trials
Hepatology Clinical Trials
Motility Clinical Trials
 

IBD Clinical Trials

Actively recruiting Crohn's Disease studies:

CALM - two treatment algorithms with adalimumab (Humira®) - a human anti-TNF monoclonal antibody

Protocol M11-271

  • An open label, multicenter, efficacy and safety study to evaluate two treatment algorithms in subjects with moderate to severe Crohn's disease. (Abbott)
  • Contact: Karen Graham 

Pfizer Phase 2 Tofacitinib – oral JAK 1/3 inhibitor

Protocol A3921083

  • A randomized, double-blind, placebo controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for Maintenance therapy in subjects with moderate to severe Crohn’s disease
  • Contact: Karen Graham 

A3921084, A3921086 (Maintenance and Open Label)

AbbVie Humira Protocol M14-115 (SERENE CD)

  • A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
  • Contact: Karen Graham 

 

 

Crohn's Disease studies currently in ethics:

AbbVie Humira Protocol M14-347 (extension of M14-115)

  • A Multicenter, Open-Label Study to  Evaluate the Efficacy and Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease 

Actively recruiting Ulcerative Colitis studies:

OCTAVE Pfizer CP-690,550  – Tofacitinib – an oral JAK 1/3 inhibitor 

Protocol A3921094 (OCTAVE1 Induction) (maintenance and open label protocols as well)

  • A phase III, Multicenter, 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
  • Contact: Karen Graham 

Robarts RP1204 – MTX and adalimumab

  • A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination with Methotrexate for Treatment of Patients with Ulcerative Colitis
  • Contact: Karen Graham 

Janssen UC Phase 2b – oral JAK 3

  • A Phase 2b, Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis
  • Contact: Karen Graham 

AbbVie Humira Protocol M14-033 (SERENE UC)

  • A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
  • Contact: Karen Graham 

Ulcerative Colitis studies currently in early stages of preparation and submission:

Genentech/Quintiles UC Phase 3 – Etrolizumab (rhuMAb β7) GA29103 (Gardenia)

  • Phase III, randomized, multi-center, double-blind, double-dummy study to evaluate the efficacy and safety of Etrolizumab compared with infliximab in patients with moderate to severe active ulcerative colitis who are naïve to TNF inhibitors

Genentech/Quintiles UC Phase 3 – Etrolizumab (rhuMAb β7) GA28950 (Hickory)

  • Phase III, blinded, placebo-controlled, multicentre study of the efficacy and safety of Etrolizumab during induction and maintenance in patients with moderate to severe active ulcerative colitis who are refractory to or intolerant to TNF inhibitors

Genentech/Quintiles UC Phase 3 – Etrolizumab (rhuMAb β7) GA28951 (Cottonwood)

  • An open-label, extension and safety monitoring study of moderate to severe ulcerative colitis patients previously enrolled in Etrolizumab Phase III studies.

To learn more about research and participation in crohn's and ulcerative colitis clinical trials, please contact: 

Karen Graham (Clinical Trials Research Nurse)
Phone: 1-403-220-6014
E-mail: kgraham@ucalgary.ca

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