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A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease

Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…

A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

To evaluate the long term maintenance of response, safety and tolerability of repeatedadministration of adalimumab in subjects with Ulcerative Colitis who participated in and successfullycompleted Protocol M06-826 or Protocol M06-827.The secondary…

The effect of Caphosol on the development of esophagitis in (N)SCLC patients treated with concurrent chemo/radiotherapy

Trial hypothesisAdding the use of Caphosol® (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the…

Lengthening Adalimumab Dosing Interval in IBD patients in long term remission, the LADI study.

To assess the safety of lengthening the adalimumab dosing interval from 2 to 3 weeks, in patients with Crohn*s disease or ulcerative colitis in long term (6 months) remission.

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…

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

Primary: Safety and tolerability. Secondary: Effectiveness, quality of life, healthcare resource utilisation, work productivity.

A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC, CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASED GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE

Primary: To determine whether or not consistent exposures can be achieved in neonates and preterm infants with presumed GERD receiving oral doses of pantoprazole. Secondary: PK and PD assessment after single dose and steady state. Determination fo…

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

Investigating the safety of adalimumab when administered in subjects with Crohn*s Disease as well as evaulating the efficacy of adalimumab for the induction and maintenance of clinical remission and fistula closure in subjects with moderate to…

Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancreatic necRosis (CONDOR trial): a prospective randomised controlled trial

To compare endoscopic transmural debridement with standard conservative treatment in patients with symptomatic sterile organized pancreatic necrosis in a randomized controlled trial with emphasis on extent and duration of recovery.

Forward viewing ultrasonic endoscope versus standard oblique viewing ultrasonic endoscope in transmural drainage of pancreatic fluid collections: A randomized controlled trial

To compare endoscopic pancreatic fluid collection drainage using a standard oblique-viewing US endoscope versus a prototype forward viewing ultrasonic endoscope with emphasis on ease of endoscopic drainage measured by procedural time.

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn*s disease

To evaluate the long-term safety of oral GED-0301 in subjects with Crohn*s disease

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Primary Objectives* To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score,in pediatric participants with moderately to severely active ulcerative colitis (UC).* To evaluate the safety profile of golimumab…

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in
Subjects with Ulcerative Colitis

The primary objective of this study is:* To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-Sponsored filgotinib treatment study in UCThe…

OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

This study has been transitioned to CTIS with ID 2023-509694-22-00 check the CTIS register for the current data. Primary objective: • To evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely…

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Primary Objective• To assess the safety and tolerability of long-term tofacitinib therapy in subjects with UC.Secondary Objectives• To evaluate the efficacy of long term tofacitinib therapy in subjects with UC.• To evaluate the effect of long term…

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn*s Disease Patients Treated with Ustekinumab

A *treat to target* strategy has been advocated as an optimized management approach for various diseases, by which strictly defined treatment targets facilitate decision making in clinical practice. Key to the success of this treatment strategy is…

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH
MODERATELY TO SEVERELY ACTIVE CROHN*S DISEASE PREVIOUSLY ENROLLED
IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

The objectives of this open-label extension*safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety…

An open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis

This is an exploratory study to assess changes in colonic inflammation after 8 weeks of treatment with tofacitinib (XELJANZ) 2 x 5 mg BID in patients with moderate to severely active UC.

A Phase 3, Multicentre, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease

This study has been transitioned to CTIS with ID 2022-502841-91-00 check the CTIS register for the current data. The main reason for this study is to help in answering the following research question: - Whether mirikizumab can help patients with…

A Prospective, Open-label Pilot Study to Evaluate Effector mechanisms of Hyperbaric Oxygen Therapy in Patients with Moderate-to-Severe Ulcerative Colitis: The PARADOX study

This study has been transitioned to CTIS with ID 2024-515278-28-00 check the CTIS register for the current data. To analyze the molecular effects and dose-response relationship of HBOT in patients with moderate-to-severe UC refractory to medical…