psoriatic arthritis
Conditions
Interventions
adalimumab
Sponsors
Nagoya City University Graduate School of Medical Sciences, Department of Geriatric and Environmental Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients having been informed sufficiently as to the objectives and design of the study and having issued written consent to the study at their own discretion (2) Patients aged 20 or older on the date of consent acquisition (3) Patients diagnosed as having psoriatic arthritis in accordance with CASPAR criteria (4) Patients poorly responding to treatment with NSAIDs (5) In cases being treated with NSAIDs, DMARDs or oral corticosteroids, patients having received the treatment at a stable dose level until 4 weeks before the start of this study
Exclusion criteria
Exclusion criteria: (1) Patients with other active skin disease possibly disturbing evaluation of psoriasis-related skin symptoms (2) Patients having received intraarticular or intratendinous injection of steroid with 4 weeks before the start of this study (3) Patients having received biological preparations during the period specified below: Infliximab: within 8 weeks before the start of this study Ustekinumab: within 12 weeks before the start of this study Other biological preparations (including drugs on clinical trial): within 24 weeks before the start of this study (4) Patients receiving ultraviolet ray therapy or using ciclosporin or etretinate at the start of this study of this study (5) Patients with serious infection (sepsis, etc.) (6) Patients with active tuberculosis (7) Patients with a history of hypersensitivity to any component of the study drug (8) Patients with demyelinating disease (multiple sclerosis, etc.) or its history (9) Patients with congestive heart failure (10) Other patients judged by the investigator or the like as inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response rate (at Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20 response rate (at Week 24), ACR50/70 response rate (at Weeks 12 and 24) Change in HAQ, change in DAS28CRP, change in BASDAI (at Weeks 12 and 24) PASI50/75/90 response rate, change in PASI, change in PGA (at Weeks 12 and 24) Change in SF-36, change in DLQI (at Weeks 12 and 24) CRP, anti-CCP antibody, SAA, change in MMP-3 (at Weeks 12 and 24) | — |
Countries
Japan
Contacts
Public ContactTatsumi Shimuzu
EPS Corporation CRO Business Division, Clinical Information Business Department
Outcome results
None listed