Clinical trials: Inflammatory Bowel Diseases (IBD)
- Condition Inflammatory Bowel Diseases (IBD)
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Inflammatory Bowel Disease
Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis
The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non-biologic exposed patients…
- Trial name
- NCT00658827
- Testing
- No intervention
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Janssen Biotech, Inc.
Ulcerative Colitis
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects…
- Trial name
- NCT04314375
- Testing
- Low Dose Budesonide, High Dose Budesonide
- Where
- 4 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bausch Health Americas, Inc.
Crohn Disease
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic…
- Trial name
- NCT00317369
- Testing
- OPC-6535(Tetomilast)
- Where
- 8 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Crohn's Disease
An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world.
- Trial name
- NCT06023030
- Where
- 104 sites in Japan
- Volunteers
- 240 people
- Sponsor
- AbbVie
Ulcerative Colitis
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate…
- Trial name
- FIGARO UC 303 (NCT03290781)
- Testing
- Ontamalimab
- Where
- 401 sites in United States, Argentina and 35 more
- Volunteers
- 366 people
- Sponsor
- Shire
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
- Trial name
- VIVID-1 (NCT03926130)
- Testing
- Mirikizumab, Ustekinumab
- Where
- 580 sites in United States, Argentina and 32 more
- Volunteers
- 1,158 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.
- Trial name
- NCT01958827
- Testing
- Adalimumab
- Volunteers
- 28 people
- Sponsor
- AbbVie
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention.
- Trial name
- AMAY (NCT05509777)
- Testing
- Mirikizumab
- Where
- 81 sites in United States, Austria and 14 more
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT00853099
- Testing
- adalimumab
- Where
- 65 sites in Japan
- Volunteers
- 274 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies.
- Trial name
- NCT05442567
- Testing
- Vedolizumab IV, No Intervention
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 240 people
- Sponsor
- Takeda
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
- Trial name
- NCT04701411
- Testing
- Darvadstrocel
- Where
- 22 sites in Israel, Japan and 3 more
- Volunteers
- 7 people
- Sponsor
- Takeda
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather…
- Trial name
- NCT00686374
- Testing
- Adalimumab
- Volunteers
- 100 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Crohn's Disease
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
- Trial name
- NCT00291668
- Testing
- Certolizumab Pegol
- Where
- 22 sites in Japan
- Volunteers
- 94 people
- Sponsor
- UCB Pharma
Ulcerative Colitis
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT06052059
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 476 sites in United States, Argentina and 43 more
- Volunteers
- 1,109 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Disease, HIV/AIDS
Observational Pharmaco-Epidemiology Research & Analysis
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management…
- Conditions
- Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases
- Trial name
- OPERA (NCT03813862)
- Testing
- Non-interventional (observational only)
- Where
- United States
- Volunteers
- 2,000,000 people, healthy volunteers welcome
- Sponsor
- Epividian
Crohn's Disease, Ulcerative Colitis
Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the…
- Trial name
- NCT06856135
- Testing
- Vedolizumab IV
- Where
- 3 sites in United States
- Sponsor
- Takeda
Ulcerative Colitis
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04706793
- Testing
- Etrasimod
- Where
- 38 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Crohn Disease, Ulcerative Colitis
The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date.
- Conditions
- Crohn Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Diseases
- Trial name
- NCT03952364
- Testing
- PredictSURE IBD™
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- PredictImmune Ltd