Clinical trials: Remission of Ulcerative Colitis
Ulcerative Colitis
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity…
- Trial name
- NCT00801723
- Testing
- Budesonide MMX 6 mg Tablet
- Where
- 58 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
- Trial name
- GEMINI I (NCT00783718)
- Testing
- vedolizumab
- Where
- 105 sites in United States, Canada and 1 more
- Volunteers
- 895 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT00385736
- Testing
- adalimumab
- Where
- 80 sites in United States, Austria and 11 more
- Volunteers
- 576 people
- Sponsor
- Abbott
Ulcerative Colitis
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and…
- Trial name
- SELECTION (NCT02914522)
- Testing
- Filgotinib, PTM filgotinib
- Where
- 343 sites in United States, Argentina and 38 more
- Volunteers
- 1,351 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis
HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis
A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy…
- Trial name
- NATRUL-4 (NCT01882764)
- Testing
- HMPL-004
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Hutchison Medipharma Limited
Ulcerative Colitis
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and…
- Trial name
- NCT00151892
- Testing
- SPD476, Asacol
- Where
- 142 sites in United States, Argentina and 26 more
- Volunteers
- 829 people
- Sponsor
- Shire
Ulcerative Colitis
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
- Trial name
- NCT00326209
- Testing
- Encapsulated Mesalamine Granules (eMG)
- Where
- 61 sites in United States
- Volunteers
- 393 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release…
- Trial name
- NCT02493712
- Testing
- High dose, Low dose
- Where
- Italy
- Volunteers
- 51 people
- Sponsor
- Holy Stone Healthcare Co., Ltd
Ulcerative Colitis
Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC
The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and its effect on long and short-term outcomes…
- Trial name
- COVET (NCT02954159)
- Testing
- Tacrolimus, Vedolizumab
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Medical College of Wisconsin
Ulcerative Colitis
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC.
- Trial name
- NCT02522767
- Testing
- Mesalamine
- Where
- 93 sites in United States, Bulgaria and 9 more
- Volunteers
- 228 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with…
- Trial name
- NCT00408629
- Testing
- adalimumab
- Where
- 108 sites in United States, Argentina and 16 more
- Volunteers
- 518 people
- Sponsor
- Abbott
Ulcerative Colitis
Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis
There are fewer therapeutic options for patients with active ulcerative colitis (UC) compared to patients with active Crohn's disease (CD) and the investigators are facing a persistent unmet need for additional effective and…
- Trial name
- Merit-UC (NCT01393405)
- Testing
- Methotrexate
- Where
- 31 sites in United States
- Volunteers
- 179 people
- Sponsor
- University of North Carolina, Chapel Hill
Ulcerative Colitis
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared…
- Trial name
- NCT01124149
- Testing
- MMX mesalamine/ mesalazine
- Where
- 105 sites in United States, Belgium and 13 more
- Volunteers
- 759 people
- Sponsor
- Shire
Ulcerative Colitis
Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)
Part 1 of this study is a 3-arm, randomized, active-controlled, parallel-group, multicenter, double-blind, double-dummy, 16-week study to compare the efficacy and safety of infliximab (IFX), as monotherapy or in combination with…
- Trial name
- NCT00537316
- Testing
- Infliximab (IFX), Azathioprine (AZA)
- Volunteers
- 242 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC.
- Trial name
- NCT02522780
- Testing
- Mesalamine
- Where
- 96 sites in United States, Bulgaria and 9 more
- Volunteers
- 276 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26…
- Trial name
- CAMPIII (NCT01004185)
- Testing
- Asacol 400 mg
- Where
- 51 sites in United States, Canada and 4 more
- Volunteers
- 39 people
- Sponsor
- Warner Chilcott
Ulcerative Colitis
Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.
- Trial name
- NCT03269695
- Testing
- PF-06687234
- Where
- 34 sites in United States, Australia and 8 more
- Volunteers
- 20 people
- Sponsor
- Pfizer
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active…
- Trial name
- HIBISCUS II (NCT02171429)
- Testing
- Adalimumab, Etrolizumab
- Where
- 90 sites in United States, Argentina and 17 more
- Volunteers
- 358 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over…
- Trial name
- CAPYBARA (NCT05479058)
- Testing
- Filgotinib
- Where
- 50 sites in United States, Belgium and 11 more
- Volunteers
- 22 people
- Sponsor
- Lakefront Biotherapeutics NV
Active Ulcerative Colitis, Remission of Ulcerative Colitis
Canadian Active & Maintenance Modified Pentasa Study
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative…
- Trial name
- CAMMP (NCT00603733)
- Testing
- 5-ASA (5-Aminosalicylate)
- Where
- 27 sites in Canada
- Volunteers
- 288 people
- Sponsor
- Ferring Pharmaceuticals