Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 April 2017 |
Main ID: |
EUCTR2014-003697-17-DE |
Date of registration:
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06/03/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
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Scientific title:
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A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis |
Date of first enrolment:
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22/04/2015 |
Target sample size:
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150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003697-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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Germany
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Poland
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Romania
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Russian Federation
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Spain
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United States
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Contacts
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
- Had active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline b. C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
- Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
- Has active PsA despite current or previous non-biologic diseasemodifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
- If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria: - Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
- Has previously received guselkumab or ustekinumab - Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
- Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
- Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Active Psoriatic Arthritis MedDRA version: 17.1
Level: LLT
Classification code 10037160
Term: Psoriatic arthritis
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Product Name: Guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Guselkumab Current Sponsor code: CNTO1959 Other descriptive name: GUSELKUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90-
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Primary Outcome(s)
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Primary end point(s): Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
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Main Objective: - To evaluate the efficacy of guselkumab in subjects with active PsA by assessing the reduction in signs and symptoms of PsA. - To assess the safety and tolerability of guselkumab in subjects with active PsA.
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Secondary Objective: The secondary objectives are: - To evaluate the efficacy of guselkumab in improving physical function. - To evaluate the impact of guselkumab on quality of life. - To evaluate the efficacy of guselkumab on psoriatic skin lesions. - To evaluate the PK and immunogenicity of guselkumab in subjects with active PsA. - To evaluate the PD characteristics of guselkumab with and without MTX in subjects with active PsA. - To evaluate the efficacy and safety of guselkumab following 1 year of exposure.
The exploratory objectives are: - To evaluate the correlation between PK and PD characteristics of guselkumab in subjects with PsA. - To use ultrasound to evaluate the changes in musculoskeletal abnormalities (enthesitis, tenosynovitis, and synovitis) from baseline in patients with active PsA treated with guselkumab as compared to placebo)
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: - secundairy end point 1, 4 & 5 at baseline & week 24
- secundairy end point 2 at week 16
- secundairy end point 3 & 6 at week 24
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Secondary end point(s): 1. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24
2. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 16
3. Percentage of Participants who Achieve an ACR 50 Response at Week 24
4. Percent Improvement in Enthesitis Scores at Week 24 Among Participants with Enthesitis at Baseline
5. Percent Improvement in Dactylitis Scores at Week 24 Among Participants with Dactylitis at Baseline
6. Percentage of Participants who Achieve a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24
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Secondary ID(s)
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CNTO1959PSA2001
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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