A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Injection
American College of Rheumatology (ACR) 20 response rate by visit
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Time frame: From Week 0 to Week 24
American College of Rheumatology (ACR) 50 response rate by visit
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Time frame: From Week 0 to Week 24
American College of Rheumatology (ACR) 70 response rate by visit
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Time frame: From Week 0 to Week 24
Change in American College of Rheumatology (ACR) the individual component by visit
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Time frame: From Week 0 to Week 24
Change in Disease Activity Score DAS28 [hsCRP] by visit
Determine by disease activity score using 28 joint counts (DAS28) and high-sensitivity C-reactive protein (hsCRP) lab test.
Time frame: From Week 0 to Week 24
Change in Psoriatic Disease Activity Score (PASDAS) by visit
PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.
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Site Reference ID/Investigator# 138922
Woolloongabba, Australia
Site Reference ID/Investigator# 138925
Plovdiv, Bulgaria
Site Reference ID/Investigator# 138926
Plovdiv, Bulgaria
Site Reference ID/Investigator# 138927
Plovdiv, Bulgaria
Site Reference ID/Investigator# 138928
Sofia, Bulgaria
Site Reference ID/Investigator# 138930
Sofia, Bulgaria
Site Reference ID/Investigator# 138929
Sofia, Bulgaria
Site Reference ID/Investigator# 138934
Prague, Czechia
Site Reference ID/Investigator# 138933
Prague, Czechia
Site Reference ID/Investigator# 138932
Uherské Hradiště, Czechia
...and 26 more locations
Time frame: From Week 0 to Week 24
Change in Psoriasis Area and Severity Index (PASI) by visit
Determined by scores for the amount and severity of a patient's psoriasis.
Time frame: From Week 0 to Week 24
Change in Psoriasis Target Lesion Score by visit
Determined by plaque erythema, plaque scaling and plaque thickness scores.
Time frame: From Week 0 to Week 24
Change in Dactylitis Assessment by visit
Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.
Time frame: From Week 0 to Week 24
Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit
Determined by the presence and severity of enthesitis.
Time frame: From Week 0 to Week 24
Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit
Determined by scores given by patients regarding the severity of their psoriatic symptoms.
Time frame: From Week 0 to Week 24
Change in skin biopsy/biomarkers
Optional samples to assess changes related on disease activity/prognosis of psoriatic arthritis (PsA), autoimmunity/inflammation, and/or response to anti-PsA medications.
Time frame: From Week 0 to Week 24
Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Time frame: From Week 0 to Week 24
Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Time frame: From Week 0 to Week 24
Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Time frame: From Week 0 to Week 24
Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Time frame: From Week 0 to Week 24