psoriatic arthritis
Conditions
Sponsors
UCB Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject is male or female at least 18 years of age -Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception -Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66 -Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies -Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO) -Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(alpha)) inhibitors for either PsA or PSO -Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion criteria
Exclusion criteria: -Female subjects who are breastfeeding(including pumping), pregnant, or plan to become pregnant during the study -Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO -Subject has an active infection or a history of recent serious infections -Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection -Subject has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to RA, sarcoidosis, systemic lupus erythematosus, reactive arthritis, Crohn's disease, or ulcerative colitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy American College of Rheumatology (ACR) 50 response at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline -Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline -Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 -Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 -Minimal Disease Activity (MDA) at Week 16 -American College of Rheumatology (ACR) 20 response at Week 16 -American College of Rheumatology (ACR) 70 response at Week 16 -Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline -Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline -Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16 -Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Week 16 -Incidence of treatment-emergent adverse events (TEAEs) during the study -Incidence of serious adverse events (SAEs) during the study -Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study | — |
Countries
Europe, Japan, North America
Outcome results
None listed