Active Psoriatic Arthritis MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • At least 18 years in age. • Male or Female. • Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria. • Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints. • Have active plaque psoriatic skin lesion. • Have at least 1 joint erosion on hand or foot x-rays as determined by the central reader OR have a hsCRP =6 milligrams per litre (0.6 mg/dL) at screening. • Participants who have active PsA despite current or prior nonsteroidal anti-inflammatory drug (NSAIDs) or conventional disease-modifying antirheumatic drugs (cDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs). • Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 4 weeks after stopping treatment. • Women must agree to use reliable birth control or remain abstinent during the study and for at least 4 weeks after stopping treatment. 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 435 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 187
Exclusion criteria
Exclusion criteria: • Have autoimmune or inflammatory conditions other than PsA that might confound the evaluation of the benefit of baricitinib therapy. • Received any Janus kinase (JAK) inhibitors (including, but not limited to, tofacitinib or baricitinib) previously or concurrently. • Serious disorder or illness other than psoriatic arthritis. • Clinically serious infection or received intravenous antibiotics for an infection, within the past 4 weeks of randomization • Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the efficacy of baricitinib 4 mg, once daily, versus placebo on signs and symptoms of arthritis as measured by ACR20 response at Week 16; Secondary Objective: 2. To compare baricitinib 4 mg, once daily, to placebo in the overall study population. 3. To compare baricitinib 2 mg, once daily, to placebo in the overall study population. 4. To compare baricitinib 4 mg, once daily, to placebo in the subgroup of biologic naïve patients. 5. To compare baricitinib 4 mg, once daily, to placebo in the overall study population. 6. To compare baricitinib 4 mg, once daily, to placebo in the overall study population ;Primary end point(s): Proportion of Participants Achieving American College of Rheumatology (ACR20) Response.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Scores 3. Proportion of Participants Achieving ACR20 Response and change from baseline in HAQ-DI 4. Proportion of Participants Achieving ACR20 Response and change from baseline in HAQ-DI 5. Change from Baseline in Modified Total Sharp Score (mTSS) 6. Proportion of Participants Achieving PASI75 Response in the Participants with Baseline Psoriatic Lesion Involving =3% Body Surface Area (BSA) AND Proportion of Patients Achieving MDAPASI AND Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in the Participants with Enthesitis at Baseline AND Change from Baseline in the Leeds Dactylitis Index - Basic (LDI-B) in the Participants with Dactylitis at Baseline ; Timepoint(s) of evaluation of this end point: Endpoints 2, 3, 5, 6: Week 16 Endpoint 4: Week 24 | — |
Countries
Argentina, Australia, China, Czech Republic, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed