Clinical trials: completed, sponsored by Janssen Research & Development, LLC
- Lead sponsor (exact) Janssen Research & Development, LLC
- Status Completed
- Age group Children (under 18)
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Advanced Solid Tumor
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations…
- Trial name
- RAGNAR (NCT04083976)
- Testing
- Erdafitinib
- Where
- 179 sites in United States, Argentina and 13 more
- Volunteers
- 316 people
- Sponsor
- Janssen Research & Development, LLC
Inherited Retinal Diseases
Global Patient Registry of Inherited Retinal Diseases
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.
- Trial name
- EYERD Registry (NCT05957276)
- Testing
- Standard of Care
- Where
- 75 sites in United States, Australia and 16 more
- Volunteers
- 886 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Juvenile
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
- Trial name
- PSUMMIT-Jr (NCT05083182)
- Testing
- Ustekinumab, Guselkumab
- Where
- 50 sites in United States, Argentina and 8 more
- Volunteers
- 48 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure…
- Trial name
- UNITI Jr (NCT04673357)
- Testing
- Ustekinumab
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 101 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Juvenile
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with…
- Trial name
- GO-VIVA (NCT02277444)
- Testing
- Golimumab, Methotrexate
- Where
- 38 sites in United States, Argentina and 7 more
- Volunteers
- 130 people
- Sponsor
- Janssen Research & Development, LLC
Attention Deficit Disorder With Hyperactivity
A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine
The purpose of this study is to estimate the observed incidence of the health outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in a cohort of participants diagnosed with…
- Trial name
- NCT04132557
- Testing
- Methylphenidate, Lisdexamfetamine, Atomoxetine
- Where
- United States
- Volunteers
- 430,000 people
- Sponsor
- Janssen Research & Development, LLC
Retinal Detachment, Achilles Tendon
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other…
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Trial name
- NCT03479736
- Testing
- Oral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Where
- United States
- Volunteers
- 117,911 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2, Cardiovascular Diseases
A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation.
- Trial name
- NCT03492580
- Testing
- Canagliflozin, Empagliflozin, Dapagliflozin
- Where
- United States
- Volunteers
- 714,582 people
- Sponsor
- Janssen Research & Development, LLC
Precursor Cell Lymphoblastic Leukemia-Lymphoma
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL)…
- Trial name
- NCT03384654
- Testing
- Daratumumab, Vincristine, Prednisone
- Where
- 53 sites in United States, Belgium and 8 more
- Volunteers
- 47 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of Ustekinumab Treatment in Children With Crohn's Disease
The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to [>=] 2 to less than [<] 18 years and weight >= 40 kilograms [kg] at…
- Trial name
- REALITI (NCT05242458)
- Testing
- Ustekinumab
- Where
- United States
- Volunteers
- 545 people
- Sponsor
- Janssen Research & Development, LLC
Epilepsy
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on…
- Trial name
- NCT02201251
- Testing
- Topiramate, Levetiracetam
- Where
- 41 sites in United States, Argentina and 12 more
- Volunteers
- 63 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing…
- Trial name
- NCT03185819
- Testing
- Midazolam, Esketamine
- Where
- 51 sites in United States, Belgium and 7 more
- Volunteers
- 147 people
- Sponsor
- Janssen Research & Development, LLC
Attention Deficit Disorder With Hyperactivity
A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
The purpose of this study is to document the extent of on-label and off-label use of Methylphenidate (MPH) (Concerta), MPH (Ritalin), Atomoxetine (ATO), and Guanfacine (GFC) in Japan.
- Trial name
- NCT04113551
- Testing
- MPH (Concerta), MPH (Ritalin), Atomoxetine (ATO)
- Where
- United States
- Volunteers
- 17,418 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, LLC
Juvenile Psoriatic Arthritis, Psoriasis
A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis
The purpose of the study is to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO).
- Conditions
- Juvenile Psoriatic Arthritis, Psoriasis, Arthritis, Juvenile
- Trial name
- U-POPS (NCT05252533)
- Testing
- Ustekinumab
- Where
- 10 sites in United States
- Volunteers
- 31 people
- Sponsor
- Janssen Research & Development, LLC
Bipolar Disorder
A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder
The primary purpose of this study is to compare, over 24 months, the time spent with clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal Interval Follow-Up Evaluation (LIFE) and the…
- Trial name
- NCT03017781
- Where
- 20 sites in United States
- Volunteers
- 224 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
An Epidemiology Study of Treatment Resistant Depression in the United States (US)
The purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and…
- Trial name
- NCT03109002
- Volunteers
- 200,000 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
- Trial name
- NCT03170518
- Testing
- Canagliflozin 100 mg, Canagliflozin 300 mg
- Where
- 106 sites in United States, Brazil and 8 more
- Volunteers
- 171 people
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
- Trial name
- Envision (NCT03664232)
- Testing
- JNJ-42165279
- Where
- 9 sites in United States
- Volunteers
- 78 people
- Sponsor
- Janssen Research & Development, LLC