A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic Arthritis
- Conditions
- Active Psoriatic ArthritisMedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-001163-37-PL
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
1. Be a man or a woman at least 18 years of age
2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet ClASsification criteria for Psoriatic ARthritis at screening
3. Have active PsA as defined by:
a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline
-AND-
b. C-reactive protein (CRP) =0.3 mg/dL at screening from the central laboratory.
4. Have 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
5. Have active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
- Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance.
- Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance.
- NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
7. Subjects may have been previously treated with up to 2 anti-TNFa agents , and must document the reason for discontinuation
a. Lack of benefit to an anti-TNFa therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14 week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
b. Intolerance to an anti-TNFa biologic therapy, as assessed by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.
c. If no intolerance or lack of benefit, the reason for discontinuation must be documented.
8. If currently using non-biologic DMARDs subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using a MTX, SSZ, or HCQ, must have not received for at least 4 weeks before first administration of study agent.
If currently not using LEF, must not have received for at least 12 weeks before first administration of study agent.
a) If using MTX, the route of administration and dose must be stable and the dose must be =25 mg/week.
b) If receiving SSZ, the dose must be = 3g/day.
c) If receiving HCQ, the dose must be =400 mg/day.
d) If receiving LEF, the dose must be =20 mg/day.
9. If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before first administration of study agent.
10. If currently using oral corticosteroids for PSA, subjects must be on a stable dose equivalent to =10 mg of prednisone/day for at least 2 weeks before first administration of study agent.
If currently not using oral corticosteroids, the subject must not have received oral corticosteroids within 2 weeks before firs
1. Has other inflammatory diseases that might confound the evaluations
of benefit of guselkumab therapy, including but not limited to RA, axial
spondyloarthritis, systemic lupus erythematosus, or
Lyme disease.
2. Has ever received more than 2 anti-TNFa agents.
3. Has received an anti-TNF agent within the following timeframes:
a. Has received infliximab or golimumab within 8 weeks before the first
administration of study agent.
b. Has received golimumab SC, adalimumab or certolizumab pegol within
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6 weeks before the first administration of study agent.
c. Has received etanercept within 4 weeks before the first administration
of study agent.
4. Has previously been treated with guselkumab.
5. Has previously received any biologic treatment, including, but not
limited to ustekinumab, abatacept, secukinumab, tildrakizumab,
ixekizumab, brodalumab, risankizumab, or other investigative biologic
treatment.
6. Has previously received tofacitinib, baricitinib, filgotinib, peficitinib,
decernotinib, or any other Janus kinase inhibitor.
7. Has previously received any systemic immunosuppressants within the
4 weeks of the first administration of study agent
8. Has received non-biologic DMARDs including, but not limited to
chloroquine, gold preparations, and penicillamine within 4 weeks before
the first administration of study agent.
9. Is currently receiving 2 or more non-biologic DMARDs at baseline.
10. Has received apremilast within 4 weeks prior to the first
administration of study agent.
16. Has unstable suicidal ideation or suicidal behavior in the last 6
months, that may be defined as an electronic Columbia-Suicide Severity
Rating Scale (eC-SSRS) rating at screening of:
- ideation level 4: some intent to act no plan, or:
- ideation level 5: specific plan and intent, OR
- any of the following suicidal behaviors:
* actual suicide attempts
* interrupted attempts
* aborted attempts
* prepartory actions
AND is confirmed to be at risk by the investigator based on an evaluation
by a mental health professional. The final decision on excluding a subject
will be made at the judgment of the investigator
38. Is seropositive for antibodies to hepatitis C virus (HCV) at screening,
unless the subject had 2 negative HCV ribonucleic acid (RNA) test results
at least 6 months apart prior to screening and have a third negative HCV
RNA test result at screening.
For a complete overview of the inclusion criteria please refer to protocol
section 4.2. (pages 60-64)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy of guselkumab treatment in subjects with active PsA by assessing the reduction in signs and symptoms of PsA.;Secondary Objective: - Efficacy in improving psoriatic skin lesions<br>- Improvement in physical function <br>- Efficacy in improving general and disease specific health-related quality of life and patient-reported health outcomes <br>- Safety <br>- Pharmacokinetics, PD, and immunogenicity<br>;Primary end point(s): The proportion of subjects who achieve an ACR 20 response at Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method