Clinical trials: Inflammatory Disease Activity
Ulcerative Colitis
Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)
Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT01716039
- Testing
- MTX 12.5, MTX 25, Adalimumab
- Volunteers
- 22 people
- Sponsor
- Alimentiv Inc.
Crohn's Disease, IBD
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or…
- Conditions
- Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease
- Trial name
- NCT01369329
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 175 sites in United States, Australia and 21 more
- Volunteers
- 769 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
- Trial name
- ASCEND I (NCT00577473)
- Testing
- mesalamine
- Where
- 44 sites in United States
- Volunteers
- 301 people
- Sponsor
- Warner Chilcott
Crohn's Disease
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are…
- Trial name
- CULTIVATE (NCT04173273)
- Testing
- Etrasimod
- Where
- 510 sites in United States, Argentina and 39 more
- Volunteers
- 379 people
- Sponsor
- Pfizer
Ulcerative Colitis
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)
The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).
- Trial name
- NCT03943550
- Testing
- RO7049665
- Where
- 6 sites in United States, Georgia and 3 more
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis (UC)
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction…
- Trial name
- NCT02819635
- Testing
- Upadacitinib
- Where
- 496 sites in United States, Argentina and 44 more
- Volunteers
- 1,302 people
- Sponsor
- AbbVie
Psoriatic Arthritis
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with…
- Trial name
- SELECT - PsA 2 (NCT03104374)
- Testing
- Upadacitinib
- Where
- 165 sites in United States, Australia and 17 more
- Volunteers
- 642 people
- Sponsor
- AbbVie
Crohn's Disease
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease.
- Trial name
- NCT01190410
- Testing
- certolizumab pegol
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 16 people
- Sponsor
- UCB Pharma
Papulopustular Rosacea
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are…
- Trial name
- MVOR-2 (NCT05343455)
- Testing
- DFD-29, Doxycycline
- Where
- 24 sites in United States, Germany
- Volunteers
- 330 people
- Sponsor
- Journey Medical Corporation
Ulcerative Colitis
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the…
- Trial name
- NCT00679432
- Testing
- Blood sampling, endoscopy, budesonide-MMX® 6 mg, budesonide-MMX® 9 mg
- Where
- 105 sites in United States, Canada and 2 more
- Volunteers
- 510 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker…
- Trial name
- EVOLUTION (NCT02318667)
- Testing
- Golimumab
- Volunteers
- 38 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Rheumatoid Arthritis
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with…
- Trial name
- NCT02706951
- Testing
- Methotrexate, Upadacitinib
- Where
- 153 sites in United States, Argentina and 23 more
- Volunteers
- 648 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
The objectives of Period 1 were the following: To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly…
- Trial name
- SELECT-EARLY (NCT02706873)
- Testing
- Methotrexate, Upadacitinib
- Where
- 290 sites in United States, Argentina and 43 more
- Volunteers
- 1,002 people
- Sponsor
- AbbVie
Colitis, Ulcerative
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
- Trial name
- NCT04779307
- Testing
- Vedolizumab
- Where
- 65 sites in United States, Australia and 12 more
- Volunteers
- 121 people
- Sponsor
- Takeda
Crohn's Disease
Efficacy and Safety of TD-1473 in Crohn's Disease
A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
- Trial name
- DIONE (NCT03635112)
- Testing
- TD-1473
- Where
- 178 sites in United States, Australia and 20 more
- Volunteers
- 167 people
- Sponsor
- Theravance Biopharma
Human Immunodeficiency Virus, Immune Reconstitution Inflammatory Syndrome
Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)
Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days). This trial will be unblinded.
- Trial name
- PUSH (NCT02063880)
- Testing
- Urgent ART, Early ART
- Where
- 4 sites in Kenya
- Volunteers
- 183 people
- Sponsor
- University of Washington
Crohn's Disease
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment…
- Trial name
- NCT00989573
- Testing
- OPC-6535
- Where
- 11 sites in Japan, South Korea
- Volunteers
- 191 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Ulcerative Colitis
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with…
- Trial name
- NCT00713310
- Testing
- Asacol 400 mg
- Where
- 42 sites in United States, Canada and 3 more
- Volunteers
- 83 people
- Sponsor
- Warner Chilcott
Colitis, Ulcerative
An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis
This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and a Mayo endoscopic subscore≥ 2.
- Trial name
- NCT02601300
- Testing
- GED-0301
- Where
- 36 sites in United States, Bulgaria and 4 more
- Volunteers
- 41 people
- Sponsor
- Celgene