The mission of our clinical research is to foster discoveries in the novel therapies of inflammatory bowel diseases, gastrointestinal and pancreatic cancer, hepatitis, and other gastrointestinal disorders. Our doctors are committed to providing the best care and management of diseases while testing cutting-edge therapies.

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Ongoing clinical trials for Crohn's disease: Actively recruiting


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

Prospective Registry in IBD Study at MGH (PRISM)

Description of study:

The purpose of the study is to increase understanding about the causes of inflammatory bowel disease (IBD) as well as the factors that may influence the course of IBD over time.

Basic eligibility criteria:

Exclusion criteria include inability or unwillingness to provide blood samples.  Patients who have known bleeding disorders are also excluded from this group.

Principal Investigator:

Ramnik Xavier, MD, PhD

Contact:

Holly Sturgeon; 617-724-7559


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease

Description of study:

The purpose of this research study is to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease exposed to certain medications or anti-TNF therapy are greater than those among IBD-affected women not taking these medications.  This information will be valuable in guiding therapy of women with IBD who wish to have children while receiving this therapy for their illness. 

Basic eligibility criteria:

Pregnant women with IBD who are exposed to immunomodulators or biologics. Women with multiple gestations are excluded.

Principal Investigator:

Deanna Nguyen, MD

Contact:

Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

PIANO: Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes

Description of study:

This research study is being done to determine whether the achievement of developmental milestones, rates of growth by height and weight, and protection against infections are reduced in the children of women with IBD. The role of medications used during pregnancy on these outcomes will also be studied.

Basic eligibility criteria:

Pregnant women with IBD who are enrolled in the National Registry study. 

Principal Investigator:

Deanna Nguyen, MD

Contact:

Melissa Cohen; 617-724-3238


Condition:

Crohn's Disease

Study title:

CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Description of study:

The purpose of CD INFORM is to collect information on serious infections, cancers, and other serious problems that occur in patients with CD treated with TYSABRI®.

Basic eligibility criteria:

Any patient enrolled in the TOUCH program is eligible to participate in CD INFORM.

Principal Investigator:

Vijay Yajnik, MD, PhD

Contact:

Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease

Study title:

CNTO1275CRD3001: 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)

Description of study:

This study aims to evaluate the efficacy and safety of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active CD who have failed or are intolerant to one or more tumor necrosis factor (TNF) antagonist therapies.

Basic eligibility criteria:

Target population consists of men or women > 18 years of age at the time of informed consent with moderately to severely active CD (of at least 3 months duration) defined as a CDAI score of > 220 and < 450, who have received inflixmab, adalimumab, or certolizumab pegol at a dose approved for the treatment of CD and either did not respond initially, responded initially but then lost response or were intolerant to the medication. Subject must have colitis, ileitis or ileocolitis previously confirmed at any time in the past by radiography, histology and/or endoscopy and must allow a > 8 week washout for prior TNF antagonist use. Subjects will be excluded if they have any complications of CD, such as symptomatic strictures or stenoses, short gut syndrome or any other manifestations that might require surgery, currently have or suspected to have an abscess, have had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline, have a draining stoma or ostomy, have a positive stool culture or positive c-diff, have various active infections (i.e. herpes, TB, HIV), or other uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral or psychiatric disease.

Principal Investigator:

Vijay Yajnik, MD, PhD

Contact:

Jacquelyn Durand; 617-724-8043 or Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease

Study title:

CNTO1275CRD3002:   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)

Description of study:

This study aims to evaluate the efficacy and safety of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active CD.

Basic eligibility criteria:

Target population consists of men or women > 18 years of age at the time of informed consent with moderately to severely active CD (of at least 3 months duration) defined as a CDAI score of > 220 and < 450, and have at least one of the following:  abnormal CRP OR fecal calprotectin > 250mg/kg at screening, OR endosocopy with evidence of active CD (defined as ulceration in the ileum and/or colon); have failed conventional therapy AND have not previously demonstrated inadequate response or intolerance to 1 or more TNF antagonist therapies.  Subject must have colitis, ileitis or ileocolitis previously confirmed at any time in the past by radiography, histology and/or endoscopy and must allow a > 8 week washout for prior TNF antagonist use.  Subjects will be excluded if they have any complications of CD, such as symptomatic strictures or stenoses, short gut syndrome or any other manifestations that might require surgery, currently have or suspected to have an abscess, have had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline, have a draining stoma or ostomy, have a positive stool culture or positive c-diff, have various active infections (i.e. herpes, TB, HIV), or other uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral or psychiatric disease.

Principal Investigator:

Vijay Yajnik, MD, PhD

Contact:

Jacquelyn Durand; 617-724-8043 or Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease

Study title:

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn's Disease (CCX114151)

Description of study:

GSK1605786A is an orally-administered chemokine antagonist which specifically blocks the migration of gut-specific T cells, which selectively home to the intestine. This study aims to assess the efficacy and safety of GSK1605786A compared to placebo as an induction therapy in subjects with moderately-to-severely active CD over 12 weeks.

Basic eligibility criteria:

Patients may be male or female, > 18 years, must have a diagnosis > 4 months in duration with small bowel and/or colonic involvement, moderately or severely active CD (defined by a CDAI score of > 220 to < 450) at baseline and one of the following: (1) elevated CRP (> ULN) plus elevated fecal calprotectin at screening OR (2) luminal ulceration visualized by screening endoscopy and as adjudicated by central endoscopy reader.  CD must have been confirmed by visualization of the GI tract within the 12 months prior to screening (or by screening endoscopy). If female patients are of child-bearing potential, they must agree to practice effective contraception. Patients must have demonstrated an inadequate response and/or intolerance/AE to at least one of the following treatments: corticosteroids, immunomodulators. Exclusionary criteria are any known celiac disease, ulcerative colitis or indeterminate colitis, any known or suspected small bowel stricture, fistulae with abscesses or fistulae likely to require surgery during the study period, any bowel surgery within 12 weeks of screening, any history of more than 3 small bowel resections or diagnosis of small bowel syndrome, extensive colonic resection, subtotal or total colectomy,  presence of ostomies or rectal pouches, use of prohibited medications, within their specified timeframes (biologic use within 8 weeks prior to screen, parenteral glucocorticoids,  immunosuppressants  and IV antibiotics within 4 weeks, rectal treatments within 2 weeks, enteral feedings, TPN, elemental diets within 2 weeks). Infectious disease exclusionary categories include positive for C. diff, HIV, positive HBsAG or Anti-HBc test or positive Hep C antibody result, or a history of tuberculosis.  Also any evidence of hepatic dysfunction, viral hepatitis, current or chronic history of liver disease, or has known hepatic or biliary abnormalities.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease

Study title:

A 52 Week Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease (CCX114157)

Description of study:

GSK1605786A is an orally-administered chemokine antagonist which specifically blocks the migration of gut-specific T cells, which selectively home to the intestine. This study aims to assess the efficacy and safety of GSK1605786A compared to placebo in maintaining remission in subjects with CD.

Basic eligibility criteria:

Subjects achieving clinical response (CDAI decrease > 100 points) and/or remission (CDAI < 150) upon completion of treatment in study CCX114151. If female patients are of child-bearing potential, they must agree to practice effective contraception for the duration of the 52 week study. Exclusionary criteria are any known celiac disease, any known or suspected small bowel stricture, enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period,  current sepsis or infections requiring IV antibiotic therapy > 2 weeks,  and evidence of hepatic dysfunction, viral hepatitis or liver function abnormalities.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease

Study title:

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn's Disease (CCX114644)

Description of study:

GSK1605786A is an orally-administered chemokine antagonist which specifically blocks the migration of gut-specific T cells, which selectively home to the intestine. This study aims to assess the safety and tolerability of GSK1605786A in subjects with CD and to assess the effectiveness of long-term treatment with GSK1605786A in subjects with CD.  Subjects will be give treatment of oral GSK1605786A 500 mg twice daily for 108 weeks.

Basic eligibility criteria:

Adult subjects who previously completed the induction study (CCX114151) without achieving clinical response or clinical remission or who previously completed the maintenance study (CCX114157) or who withdrew from the maintenance study due to worsening of CD. If female patients are of child-bearing potential, they must agree to practice effective contraception for the duration of the 52 week study. Exclusionary criteria are any known celiac disease, any known or suspected small bowel stricture, enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period,  current sepsis or infections requiring IV antibiotic therapy > 2 weeks,  and evidence of hepatic dysfunction, viral hepatitis or liver function abnormalities.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Melissa Cohen; 617-724-3238