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Clinical trials in systemic lupus erythematosus: a status report on ongoing trials

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Abstract

To describe the characteristics of trials in systemic lupus erythematous (SLE) listed in ClinicalTrials.gov such as study design, funding sources and aspects of the disease and drugs under investigation. We conducted a survey of ongoing clinical trials that were registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, “SLE,” “open studies,” “interventional,” and “adults 18 years or older.” Of 97 eligible studies, 34.0 % were phase 3 or 4, 49.5 % were phase 1, 2 or 2/3 and in 16.5 %, we could not determine the study phase. Most trials were randomized (69.0 %) and 48.4 % were double blinded; 34 % of the trials were placebo controlled, 19.6 % had an active agent comparator and 46.4 % had no comparator. Universities and pharmaceutical industries were the primary sponsors for 45.3 and 39.1 % of the trials, respectively, and government agencies for 10.3 %. Multi-center trials based in the USA (US) accounted for 40.2 % of the trials, 46.4 % were outside of the US and 13.4 % were in the US as well as other countries. The most frequently used endpoint was drug efficacy (30.9 %) followed by disease severity indices (25.7 %), drug safety (14.4 %), remission rates and times to remission (7.2 %), and inflammatory markers and antibody titers (7.2 %). The majority of ongoing clinical trials in SLE are university or industry-funded, randomized phase 1, 2, or 2/3 trials, focused on drug efficacy. Federal funding for trials in SLE within and outside the US remains low.

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References

  1. Yildirim-Toruner C, Diamond B (2011) Current and novel therapeutics in treatment of SLE. J Allergy Clin Immunol 127(2):303–314. doi:10.1016/j.jaci.2010.12.1087

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  2. Crispin JC, Liossis SN, Kis-Toth K, Lieberman LA, Kyttaris VC, Juang YT, Tsokos GC (2010) Pathogenesis of human systemic lupus erythematous: recent advances. Trends Mol Med 16(2):47–57. doi:10.1016/j.molmed.2009.12.005

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  3. Bongu A, Chang E, Ramsey-Goldman R (2002) Can morbidity and mortality of SLE be improved? Best Pract Res Clin Rheumatol 16(2):313–332. doi:10.1053/berh.2001.0228

    Article  PubMed  Google Scholar 

  4. Paul JR, Ranganathan P (2011) Clinical trials in rheumatoid arthritis: a status report from the Clinical Trials.gov website. Rheumatol Int 32:1831–1835. doi:10.1007/s00296-011-2027-3

    Article  PubMed  Google Scholar 

  5. Gillen JE, Tse T, Ide NC, McCray AT (2004) Design, implementation and management of a web-based data entry system for ClinicalTrials.gov. Stud Health Technol Inform 107:1466–1470. doi:10.3233/978-1-60750-949-3-1466

    PubMed  Google Scholar 

  6. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S et al (2004) International committee of medical journal editors. Clinical trial registration: a statement from the international committee of medical journal editors. JAMA 292:1363–1364. doi:10.1056/NEJMe048225

    Article  CAS  PubMed  Google Scholar 

  7. Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 63(8):834–840. doi:10.1016/j.jclinepi.2010.02.005

    Article  PubMed  Google Scholar 

  8. Lewis JA, Jonsson B, Kreutz G, Sampaio C, Zwieten-Boot VB (2002) Placebo controlled trials and the declaration of Helsinki. Lancet 359(9314):1137–1140. doi:10.1016/S0140-6736(02)08277-6

    Article  Google Scholar 

  9. Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA et al (2009) A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum 61(9):1168–1178. doi:10.1002/art.24699

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  10. Runkel L, Stacey J (2014) Lupus clinical development: will belimumab’s approval catalyse a new paradigm for SLE drug development? Expert Opin Biol Ther 14(4):491–501. doi:10.1517/14712598.2014.884065

    Article  CAS  PubMed  Google Scholar 

  11. Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:1167–1170. doi:10.1136/bmj.326.7400.1167

    Article  PubMed Central  PubMed  Google Scholar 

  12. Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C et al (2003) Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 289:1107–1116. doi:10.1001/jama.289.9.1107

    Article  PubMed  Google Scholar 

  13. Dall’Era M, Wofsy D (2006) Clinical trial design in systemic lupus erythematous. Curr Opin Rheumatol 18:476–480. doi:10.1097/01.bor.0000240357.22680.63

    Article  PubMed  Google Scholar 

  14. Strand V, Gladman D, Isenberg D, Petri M, Smolen J, Tugwell P (2000) Endpoints: consensus recommendations from OMERACT IV. Lupus 9(5):322–327

    Article  CAS  PubMed  Google Scholar 

  15. Thanou A, Merrill JT (2014) Treatment of systemic lupus erythematous: new therapeutic avenues and blind alleys. Nat Rev Rheumatol 10(1):23–24. doi:10.1038/nrrheum.2013.145

    Article  CAS  PubMed  Google Scholar 

  16. Avery DT, Kalled SL, Ellyard JI, Ambrose C, Bixler SA, Thien M, Brink R et al (2003) BAFF selectively enhances the survival of plasmablasts generated from human memory B cells. J Clin Invest 112(2):286–297. doi:10.1172/JCI18025

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  17. Haubitz M (2010) New and emerging treatment approaches to lupus. Biologics 4:263–271. doi:10.2147/BTT.S7581

    CAS  PubMed Central  PubMed  Google Scholar 

  18. Abu-Shakra M, Buskila D (2002) Update on the treatment of systemic lupus erythematous: therapeutic highlights from the sixth international lupus conference. Isr Med Assoc J 4(1):71–73

    CAS  PubMed  Google Scholar 

  19. Anolik J (2005) New treatments for SLE: cell-depleting and anti-cytokine therapies. Best Pract Res Clin Rheumatol 19(5):859–878. doi:10.1016/j.berh.2005.05.006

    Article  CAS  PubMed  Google Scholar 

  20. Baechler EC, Batliwalla FM, Karypis G, Gaffney PM, Ortmann WA, Espe KJ, Shark KB et al (2003) Interferon-inducible gene expression signature in peripheral blood cells of patients with severe lupus. Proc Natl Acad Sci USA 100(5):2610–2615. doi:10.1073/pnas.0337679100

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  21. Burt RK, Traynor A, Statkute L, Barr WG, Rosa R, Schroeder J, Verda L et al (2006) Nonmyeloablative hematopoietic stem cell transplantation for systemic lupus erythematous. JAMA 295(5):527–535. doi:10.1001/jama.295.5.527

    Article  CAS  PubMed  Google Scholar 

  22. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A (2012) Characteristics of clinical trials registered in ClinicalTrials.gov, 2007–2010. JAMA 307(17):1838–1847. doi:10.1001/jama.2012.3424

    Article  CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. St. Louis University School of Medicine, St. Louis, MO, USA

    Divya Gumber

  2. Division of Rheumatology, Department of Medicine, Washington University School of Medicine, 660 S. Euclid, Box 8045, St Louis, MO, 63110, USA

    Jisna Paul & Prabha Ranganathan

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  1. Divya Gumber
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  2. Jisna Paul
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  3. Prabha Ranganathan
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Correspondence to Prabha Ranganathan.

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Gumber, D., Paul, J. & Ranganathan, P. Clinical trials in systemic lupus erythematosus: a status report on ongoing trials. Rheumatol Int 34, 1633–1638 (2014). https://doi.org/10.1007/s00296-014-3018-y

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