A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Summary
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Timeline
- Start
- 2011-03-31
- Primary completion
- 2013-11-14
- Completion
- 2014-04-17
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority or other test); Placebo vs Sifalimumab 1,200 mg; p = 0.031; Odds Ratio (OR) 1.84 (90% CI 1.16 to 2.94); Regression, Logistic reads as mixed primary results NCT01283139 ↗
registry analysis (superiority or other test); Placebo vs Sifalimumab 200 Milligram (mg); p = 0.057; Odds Ratio (OR) 1.71 (90% CI 1.03 to 2.71); Regression, Logistic reads as mixed primary results NCT01283139 ↗
registry analysis (superiority or other test); Placebo vs Sifalimumab 200 Milligram (mg); p = 0.042; Odds Ratio (OR) 1.88 (90% CI 1.13 to 3.14); Regression, Logistic reads as mixed primary results NCT01283139 ↗
registry analysis (superiority or other test); Placebo vs Sifalimumab 600 mg; p = 0.264; Odds Ratio (OR) 1.41 (90% CI 0.85 to 2.35); Regression, Logistic reads as mixed primary results NCT01283139 ↗
release “Sifalimumab meets primary endpoint of reduction in global disease activity score (SRI-4), and shows clinically important improvement in skin and joint symptoms” reads as met primary endpoint astrazeneca.com ↗
Publications
- Background Khamashta M, Merrill JT, Werth VP, Furie R, Kalunian K, Illei GG, Drappa J, Wang L, Greth W; CD1067 study investigators. Sifalimumab, an anti-interferon-alpha monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Nov;75(11):1909-1916. doi: 10.1136/annrheumdis-2015-208562. Epub 2016 Mar 23.
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sifalimumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 1200 mg | Intravenous |