sponsored
PatientsVille.com Logo

PatientsVille

Stelara Medical Research Studies

Up-to-date List of Stelara Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Stelara Medical Research Studies

Rank Status Study
1 Not yet recruiting A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
Condition: Healthy
Intervention: Drug: Ustekinumab
Outcome Measures: Maximum Observed Plasma Concentration (Cmax);   Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf]);   Number of participants with adverse events (AEs) and serious adverse events (SAEs);   Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last]);   Terminal half-life (T1/2);   Total systemic clearance (CL);   Volume of distribution (Vz);   Number of participants with antibodies to ustekinumab
2 Recruiting Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris
Condition: Psoriasis
Interventions: Biological: Ustekinumab;   Biological: Abatacept;   Drug: Placebo for Ustekinumab;   Drug: Placebo for Abatecept
Outcome Measures: The proportion of participants who experience a psoriasis relapse at any time between week 12 and week 88;   The proportion of randomized participants who experience a psoriasis disease relapse prior to week 40.;   The proportion of participants who experience a psoriasis disease relapse between week 28 and week 88.;   The proportion of participants who experience a psoriasis disease relapse between week 40 and week 88.;   Mean length of time after week 12 to psoriasis relapse.;   Physician's Global Assessment (PGA) of cleared or minimal at week 40 and week 88.;   Dermatology Life Quality Index (DLQI);   Frequency and severity of all AEs and SAEs.
3 Not yet recruiting A Study to Evaluate the Effectiveness of Stelara ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis
Conditions: Scalp Psoriasis;   Plaque Psoriasis
Interventions: Drug: Ustekinumab;   Drug: Placebo
Outcome Measure: s-PGA ( Scalp specific Physician Global Assessment) at Week 12
4 Recruiting A Study of Ustekinumab (Stelara®) in Adult Japanese Participants With Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
Interventions: Drug: Ustekinumab;   Drug: Placebo;   Other: Concomitant topical medications for atopic dermatitis
Outcome Measures: Percent change from Baseline to Week 12 in the Eczema Area and Severity Index (EASI) score;   Percentage of participants with an Investigator's Global Assessment (IGA) score of "clear" or "almost clear" at Week 12;   Change from Baseline to Week 12 in Atopic Dermatitis Itch Scale (ADIS);   Change from Baseline to Week 12 in Dermatology Life Quality Index (DLQI)
5 Recruiting A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Conditions: Crohn's Disease;   Inflammatory Bowel Disease;   IBD;   Colitis
Interventions: Drug: Group 3: ustekinumab approximately 6 mg/kg;   Drug: Group 1: Placebo;   Drug: Group 2 ustekinumab 130 mg
Outcome Measures: Clinical Response;   Clinical remission;   Clinical improvement/response
6 Recruiting Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis
Condition: Atopic Dermatitis
Interventions: Drug: Ustekinumab;   Other: Placebo
Outcome Measures: A 50% or greater improvement from their baseline objective SCORAD (SCORing Atopic Dermatitis) at Week 16.;   Determine whether there is a reversal of the pathological epidermal phenotype during ustekinumab therapy and what immune pathways are suppressed during treatment with the drug at week 16.;   The proportion of subjects who achieve an improvement of 50% or greater from their baseline objective SCORAD at Week 32 (If patient received placebo first).;   Measured effects on patient quality of life using the DLQI (Dermatology Life Quality Index).;   The change in SCORAD from week16 to week 32 for patients that were treated with Ustekinumab from weeks 0-16, to measure maintenance of response after discontinuation of treatment.;   Ustekinumab's effect on the pathologic epidermal hyperplasia of lesional and non-lesional AD skin.;   Ustekinumab's suppression of expression of excess p40 production in non-lesional AD skin (decreasing systemic immune activation).;   Correlation between clinical response (measured via a decrease in SCORAD) to therapy with ustekinumab and suppression of the immune pathways (Th2, Th17, and Th22).
7 Not yet recruiting Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D
Condition: Type 1 Diabetes
Intervention: Drug: Ustekinumab
Outcome Measures: Primary Safety Endpoints (composite outcome measure);   Immunological Endpoints (composite outcome measure);   Exploratory (composite outcome measure)
8 Recruiting Stelara Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Conditions: Psoriasis;   Pregnancy
Intervention:
Outcome Measures: Major structural malformations;   Minor Congenital Structural Malformations
9 Not yet recruiting Ustekinumab for Active Sight-Threatening Uveitis
Condition: Uveitis
Intervention: Drug: Ustekinumab
Outcome Measure: The primary outcome is the number of participants who experience at least a 2-step (or down to grade 0) reduction in inflammation as per the Standardization of Uveitis Nomenclature (SUN) criteria by Week 8.
10 Recruiting Swiss Dermatology Network of Targeted Therapies (SDNTT)
Condition: Psoriasis
Interventions: Biological: Adalimumab;   Biological: Etanercept;   Biological: Infliximab;   Biological: Ustekinumab;   Drug: Cyclosporine A;   Drug: Fumaric acids;   Drug: Methotrexate;   Drug: Other anti-psoriatic systemic treatments
Outcome Measures: Psoriasis Area Severity Index (PASI);   Dermatology Life Quality Index (DLQI)
11 Recruiting Ustekinumab Quality of Life Study
Condition: Psoriasis
Intervention: Drug: Ustekinumab
Outcome Measures: Improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 36 from baseline.;   Change in Psychological General Well-Being scale (PGWB) over time (at Weeks 12 and 24);   Change in Work Productivity and Activity Impairment scale (WPAI-PSO) over time (at Weeks 12, 24, and 36);   Psoriasis Quality of Life - 12 items (PQOL-12) over time (at Weeks 12, 24, and 36);   Dermatology Life Quality Index (DLQI) over time (at Weeks 12, 24, and 36);   Percentage of patients achieving PASI <5 at weeks 12, 24, and 36;   Percentage of patients achieving PGA of clear or almost clear at weeks 12, 24, and 36;   Percentage of patients achieving NAPSI-75 at weeks 12,24, and 36;   Safety
12 Recruiting Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
Condition: Chronic Plaque Type Psoriasis
Interventions: Drug: secukinumab 300 mg;   Drug: ustekinumab 45/90 mg sc and placebo secukinumab
Outcome Measures: PASI 90;   Speed of onset
13 Recruiting BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
Condition: Psoriasis
Interventions: Drug: BI 655066;   Drug: Ustekinumab
Outcome Measures: Achievement of >/= 90% reduction from baseline PASI score (PASI90) at week 12;   Achievement of >/= 50% reduction from baseline in PASI score (PASI50) at week 12;   Achievement of PASI90 at week 24;   Achievement of sPGA clear or almost clear at week 12;   Achievement of >/=75% reduction from baseline in PASI score (PASI75) at week 12 and 24;   Achievement of 100% reduction from baseline in PASI score (PASI100) at week 12;   Percentage of PASI reduction from baseline at week 12;   Time to loss of PASI50 response. This endpoint is calculated from the first treatment to first < 50% reduction of PASI score compared with baseline after the response has been achieved
14 Recruiting Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis
Condition: Psoriasis
Interventions: Drug: etanercept;   Drug: ustekinumab;   Drug: cyclosporine
Outcome Measures: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis;   Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis;   Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis;   Differences and similarities in endothelial function between psoriasis and control groups;   Differences and similarities in vascular function between psoriasis and control groups;   Differences and similarities in cardiac function between psoriasis and control groups
15 Recruiting PsoBest - The German Psoriasis Registry
Conditions: Psoriasis;   Psoriatic-arthritis
Intervention:
Outcome Measures: Psoriasis Area Severity Index (PASI);   Dermatology Life Quality Index (DLQI)
16 Recruiting Spanish Registry of Systemic Treatments in Psoriasis
Condition: Psoriasis
Intervention:
Outcome Measures: Serious Adverse Events;   Other adverse events leading to changes in drug therapy or unexpected visits to health provider
17 Not yet recruiting Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis
Condition: Psoriasis
Interventions: Drug: Methotrexate;   Drug: Cyclosporins;   Drug: fumaric acid;   Drug: Acitretin;   Drug: Infliximab;   Drug: etanercept;   Drug: Adalimumab;   Drug: Ustekinumab
Outcome Measure: Cost per quality-adjusted life year (QALY) gained through treatment with each individual agent compared to supportive care as well as compared to placebo
18 Recruiting Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
Conditions: Psoriasis;   Atherosclerosis
Intervention: Drug: biological treatment
Outcome Measures: Coronary calcium score;   Cardiovascular risk markers;   interleukines in blood;   traditional cardiovascular risk factors
19 Recruiting An Exploratory Genetic Study in Participants With Psoriasis
Condition: Psoriasis
Intervention: Drug: No Intervention
Outcome Measure: Percentage of Responders With Association Between Clinical Response and Genetic Factor
20 Recruiting Clinical Assessment and Psychosocial Impact of Psoriasis
Condition: Psoriasis
Intervention:
Outcome Measures: prevalence of alexithymia;   psoriasis disease duration;   psoriasis disease severity;   anxiety and depression;   problematic drinking;   smoking;   physical and mental/emotional quality of life;   work and activity impairment related to psoriasis;   alexithymia prevalence rate

These studies may lead to new treatments and are adding insight into Stelara etiology and treatment.

A major focus of Stelara research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


Discuss Stelara