Clinical trials: Inflammatory Disorder
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
Inflammatory Bowel Disease, Ulcerative Colitis
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.
- Trial name
- NCT00486031
- Testing
- Balsalazide Disodium
- Where
- 95 sites in United States
- Volunteers
- 443 people
- Sponsor
- Bausch Health Americas, Inc.
Edema, Erythema
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back…
- Conditions
- Edema, Erythema, Estrogen Receptor Negative, HER2/Neu Negative
- Trial name
- NCT02411656
- Testing
- Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- M.D. Anderson Cancer Center
Crohn Disease
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of…
- Trial name
- NCT04362254
- Testing
- Spesolimab
- Where
- 7 sites in Austria, Belgium and 3 more
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Ulcerative Colitis
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
- Trial name
- NCT02039505
- Testing
- Vedolizumab
- Where
- 59 sites in Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
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 Disease
A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease.
- Trial name
- NCT04978493
- Testing
- BI 706321, Ustekinumab
- Where
- 49 sites in United States, Belgium and 9 more
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Post-ERCP Acute Pancreatitis
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
- Trial name
- NCT01774604
- Testing
- Indomethacin
- Where
- United States
- Volunteers
- 449 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Sepsis, Critical Illness
Optimizing Vancomycin Therapy in Children
The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under…
- Conditions
- Sepsis, Critical Illness, Infections, Drug Toxicity
- Trial name
- Opt Vanc (NCT05691309)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Children's Hospital of Philadelphia
Non-inflammatory Degenerative Joint Disease
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
- Trial name
- ASR (NCT00561600)
- Testing
- ASR™-XL Modular Acetabular Cup System, Pinnacle™ acetabular shell
- Where
- 8 sites in United States
- Volunteers
- 265 people
- Sponsor
- DePuy Orthopaedics
Sepsis Syndrome
Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis
The objective of this randomized clinical trial is to test whether administration of live attenuated MMR vaccine (measles mumps rubella; Merck) to eligible adults at highest risk for contracting COVID-19 (healthcare workers…
- Trial name
- NCT04475081
- Testing
- MMR vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
Crohn Disease
Triple Combination Therapy in High Risk Crohn's Disease (CD)
The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an…
- Trial name
- NCT02764762
- Testing
- Vedolizumab, Adalimumab, Methotrexate
- Where
- 32 sites in United States, Canada
- Volunteers
- 55 people
- Sponsor
- Takeda
Pre-Eclampsia, Pre-Term
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease.
- Conditions
- Pre-Eclampsia, Pre-Term, Intrauterine Growth Restriction, Hypertension in Pregnancy
- Trial name
- VIA (NCT04633551)
- Testing
- Anti-inflammatory supplement
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Avascular Necrosis, Osteoarthritis, Hip
Allofit® IT With HXPE in Total Hip Arthroplasty
The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary…
- Conditions
- Avascular Necrosis, Osteoarthritis, Hip, Inflammatory Arthritis, Post-Traumatic Osteoarthritis of Hip
- Trial name
- NCT03672929
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 197 people
- Sponsor
- Zimmer Biomet
Nervous System Malformations, Arthropathy, Neurogenic
Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease
This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and…
- Conditions
- Nervous System Malformations, Arthropathy, Neurogenic, Urticaria, Papilledema
- Trial name
- NCT00069329
- Testing
- anakinra
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Infections, Vector Borne Diseases
Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum
This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP).
- Conditions
- Infections, Vector Borne Diseases, Systemic Inflammatory Response Syndrome, Inflammation
- Trial name
- NCT05979207
- Testing
- MMV367 3mg, P. falciparum IBSM infection, MMV367 5mg
- Where
- 2 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Multiple Sclerosis
Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study
Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares.
- Trial name
- NCT00273364
- Testing
- Hematopoietic Stem Cell Therapy, Standard treatment with a conventional drug
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Northwestern University
Reflux Esophagitis, Gastric Ulcer
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and…
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Trial name
- NCT03553563
- Testing
- D961H capsule 10mg, D961H sachet 10mg
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
- Trial name
- NCT00446849
- Testing
- MMX Mesalamine
- Where
- 62 sites in United States
- Volunteers
- 290 people
- Sponsor
- Shire
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