Clinical trials: Inflammatory Bowel Disease
Crohn's Disease
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
- Trial name
- NCT00348283
- Testing
- adalimumab
- Where
- 21 sites in United States, Austria and 6 more
- Volunteers
- 135 people
- Sponsor
- Abbott
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Crohn Disease
Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice.
- Trial name
- STELARA CD PMS (NCT03942120)
- Testing
- Ustekinumab
- Where
- 43 sites in South Korea
- Volunteers
- 685 people
- Sponsor
- Janssen Korea, Ltd., Korea
Inflammatory Bowel Diseases, Colitis, Ulcerative
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- VEDO TDM RWE (NCT04567628)
- Testing
- No Intervention
- Where
- Canada
- Volunteers
- 7,873 people
- Sponsor
- Takeda
Mild-to-moderate Ulcerative Colitis
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (FC) (substance that is…
- Trial name
- OPTIMISE (NCT04340895)
- Testing
- Faecal Calprotectin Home Test, PRO-2 Scoring
- Where
- 42 sites in Czechia, Hungary and 4 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Crohn's Disease
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
- Trial name
- NCT03870334
- Testing
- BT-11 880 mg
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NImmune Biopharma
Alopecia Areata, Depressive Episode
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and…
- Conditions
- Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders
- Trial name
- NCT04239521
- Testing
- Exposure of interest (studies 2 & 3).
- Where
- United Kingdom
- Volunteers
- 51,955 people
- Sponsor
- Momentum Data
Colitis, Ulcerative
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
- Trial name
- NCT00151944
- Testing
- SPD476 (mesalazine)
- Volunteers
- 400 people
- Sponsor
- Shire
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Ulcerative Colitis
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in…
- Trial name
- NCT00347048
- Testing
- tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Colitis, Ulcerative
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative…
- Trial name
- NCT00503243
- Testing
- Delayed and extended release mesalazine
- Where
- United States
- Volunteers
- 280 people
- Sponsor
- Shire
Crohn's Disease
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease
This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled, sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 3…
- Trial name
- NCT02249078
- Testing
- E6011
- Sponsor
- Eisai Inc.
Ulcerative Colitis (UC)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the…
- Trial name
- NCT03398148
- Testing
- risankizumab IV, risankizumab SC
- Where
- 430 sites in United States, Argentina and 42 more
- Volunteers
- 1,558 people
- Sponsor
- AbbVie
Inflammatory Bowel Disease, Irritable Bowel Syndrome
BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS
The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC)…
- Trial name
- NCT02351635
- Testing
- fecal calprotectin level
- Where
- 7 sites in United States
- Volunteers
- 478 people, healthy volunteers welcome
- Sponsor
- Bühlmann Laboratories AG
Ulcerative Colitis
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
- Trial name
- NCT00279435
- Testing
- visilizumab
- Where
- 39 sites in United States, Australia and 13 more
- Volunteers
- 25 people
- Sponsor
- Facet Biotech
Ulcerative Colitis
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- NCT05570006
- Testing
- ABBV-668
- Where
- 30 sites in United States, Belgium and 2 more
- Volunteers
- 30 people
- Sponsor
- AbbVie
Arthritis, Rheumatoid, Crohn Disease
A Long-term Safety Study of Infliximab (Remicade)
This is a study evaluating the long-term safety of infliximab (Remicade)
- Conditions
- Arthritis, Rheumatoid, Crohn Disease, Psoriasis
- Trial name
- NCT00261976
- Testing
- Infliximab (Remicade)
- Where
- 205 sites in United States, Argentina and 17 more
- Volunteers
- 2,971 people
- Sponsor
- Centocor, Inc.
Ulcerative Colitis
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative…
- Trial name
- SELECTIONLTE (NCT02914535)
- Testing
- Filgotinib
- Where
- 323 sites in United States, Argentina and 37 more
- Volunteers
- 1,173 people
- Sponsor
- Alfasigma S.p.A.
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