Systemic Lupus Erythematosus
Conditions
Interventions
investigational material(s)
Generic name etc : PF-06700841
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investi
Sponsors
Pfizer R&D Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *Male and/or female subjects between >=18 and <=75 years of age inclusive. *Diagnosis of moderate to severe active Lupus. *Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *Active renal lupus *Severe active central nervous system (CNS) lupus *Have cancer or a history of cancer within 5 years of screening. *Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. *Active bacterial, viral, fungal, mycobacterial or other infections *Psychiatric condition including recent or active suicidal ideation or behavior *Have active fibromyalgia/myofascial/chronic pain. *Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52 - Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52 - Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to 7.5 mg/Day (or Equivalent) at Baseline - Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to 7.5 mg/Day (or Equivalent) at Baseline - Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10 - Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52 - Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52 - Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52 - Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52 - Change From Baseline in Pain Domain Scores of LupusQoL at Week 52 - Change From Baseline in Planning Domain Scores of LupusQoL at Week 52 - Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52 - Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52 - Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52 - Incidence Rate of Severe Flare Event - Number of Participants With Treatment-Emergent Adverse Events (AE) - Number of Participants With Serious Adverse Events (SAEs) - Number of Participants With Adverse Events Leading to Discontinuation From Study - Number of Participants With Clinically Significant Vital Signs Abnormalities - Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities - Number of Participants With Laboratory Test Abnormalities | — |
Countries
Japan, North America
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed