A Phase 3 interventional study of Anti JAK1,2 and Cyclophosphamid in Lupus Nephritis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.
Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.
The baricitinib 4 mg dose suggestive to significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the idea for future trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 156 interventional studies indexed under Nephritis.
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Exclusion Criteria:
oral tablet 4 mg baricitinib and placebo IV infusion/ month
Drug: Anti JAK1,2
IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily
Drug: Cyclophosphamid
Induction of remission of active lupus nephritis
Also known as: Baritava
Induction of remission of active lupus nephritis
Also known as: Indoxan
Album in urine
24 h protein in urine
Time frame: 6 months
complement 3
serum level
Time frame: 3 and 6 months
anti double strand DNA
serum level
Time frame: 3 and 6 months
lupus activity index-2K
SLEDAI-2k
Time frame: 3 and 6 months
Plan to share: No — After completing the study and published
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Assiut University