A Study of the Efficacy and Safety of Guselkumab and Golimumab in Participants with Active Psoriatic Arthritis
- Conditions
- Active Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-002012-31-HU
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
- Be =18 to =65 years of age, inclusive.
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
- Have a diagnosis of PsA for =6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening.
- Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and, hsCRP =0.3 mg/dL at screening from the central laboratory
- Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal insufficiency, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances.
- Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months prior to screening or a cardiac hospitalization within the last 3 months prior to screening.
- Has a history of, or concurrent, congestive heart failure, including medically controlled, asymptomatic congestive heart failure.
- Has a history of a demyelinating disorder such as multiple sclerosis or optic neuritis.
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to RA, AS, nr-AxSpA, systemic lupus erythematosus, or lyme disease.
For the complete overview of the exclusion criteria, please refer to
section 5.2 of the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of guselkumab+golimumab combination treatment in participants with active PsA and IR to a prior anti-TNFa therapy by assessing clinical response compared with guselkumab monotherapy;Secondary Objective: - Efficacy: To evaluate the efficacy of guselkumab+golimumab combination treatment in participants with active PsA and<br>IR to a prior anti-TNFa therapy by assessing the reduction in signs and symptoms of PsA compared with guselkumab monotherapy<br>- Safety: To evaluate the safety of guselkumab+golimumab combination treatment in participants with active PsA compared with guselkumab monotherapy<br>- PK and Immunogenicity: To evaluate the PK and immunogenicity of<br>guselkumab+golimumab combination treatment in participants with active PsA compared with guselkumab monotherapy;Primary end point(s): Proportion of participants who achieve MDA at Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Proportion of participants who achieve ACR 50 at Week 24<br>- Proportion of participants who achieve MDA at Week 16<br>- Proportion of participants who achieve Psoriasis Area and Severity Index 90/100 at Week 24 among the participants with =3% BSA psoriatic involvement and an IGA score of =2 at baseline<br>- Proportion of participants with an Investigator Global Assessment-psoriasis response at Week 24 among participants with =3% BSA psoriatic involvement and an IGA score of =2 at baseline<br>- Change from baseline in Health Assessment Questionnaire Disability Index at Week 24<br>- Resolution of enthesitis at Week 24 among the participants with enthesitis at baseline<br>- Resolution of dactylitis at Week 24 among the participants with dactylitis at baseline<br>- Change from baseline in Short Form Health Survey Physical Component Score (PCS) at Week 24;Timepoint(s) of evaluation of this end point: Week 16 and 24