Hydroxychloroquine in Systemic Lupus Erythematosus

NCT03802188 | Unknown

• 1 other identifier: MP-37-2019-4340
• Study Type: observational
• Target: 3,700
• Locations: 1 country
• Sites: 1

Brief Summary

A Systemic lupus erythematosus, SLE is disease in which immune system is over-active causing inflammation in joints skin or any organ system. There are many areas where better approaches in SLE could improve outcomes. One example relates to hydroxychloroquine (HCQ) key drug which can reduce risk of serious disease flares. There are increasing concerns about eye damage main side effect with long-term use of HCQ. At present investigators cannot precisely predict which SLE patient is most likely to flare once HCQ is tapered. It is not clear what drives risk of eye damage. Investigators' study will fill these knowledge gaps. Investigators' hypothesis is that baseline demographic and clinical factors are associated with risk of SLE flare after HCQ taper/discontinuation and with risk of retinal toxicity in all HCQ exposed patients. Research will link and analyze data on 3700 SLE patients across Canada.

Conditions

Systemic Lupus Erythematosus

Keywords

Retinal toxicity

Outcome Measures

Primary Outcomes (1)

• Proportion of SLE flares with decrease or discontinuation of HCQ

  In patients exposed to HCQ, presence or absence of SLE flare will be measure with SLEDAI-2K. The SLEDAI-2K is a reliable, validated, widely used global score index, consisting of 24 weighted clinical and laboratory variables of nine organ systems. The scores of descriptors range from 1 to 8, and the total score of the SLEDAI-2K is the sum of all 24 descriptor scores. An increase of 4 points or more has been validated as indicating a clinically significant increase in SLE disease activity.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Proportion of participants hospitalized with decrease or discontinuation of HCQ

  Through study completion, an average of 1 year

• Proportion of SLE flares relative to augmented SLE therapy

  Through study completion, an average of 1 year

• Correlation of retinal toxicity and exposure to HCQ and retinal toxicity

  Through study completion, an average of 1 year

Study Arms (2)

SLE Cohort

Investigators will use existing data collected on adult SLE patients enrolled into respective study cohorts from participating centers.

Qualitative group

For the interviews, patients with SLE who are currently or have taken Hydroxychloroquine will be recruited from rheumatology clinics in Calgary and Montreal to participate in an interview and/or participate in a brief survey.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will use existing data collected on adult SLE patients who have been consecutively enrolled into the respective study cohorts of the participating researchers in Montreal , Quebec City, Halifax, Winnipeg, Calgary, and Toronto. The total exceeds 3,300 SLE patients who have been exposed to HCQ.

You may qualify if:

• Must be 18 years of age or over
• Must be diagnosed with Systemic Lupus Erythematosus (SLE)
• Must be exposed to hydroxychloroquine
• Must be enrolled at participating sites

You may not qualify if:

• Under 18 years of age
• Not diagnosed with SLE
• Not exposed to hydroxychloroquine
• Not enrolled at participating sites

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Laval University: collaborator
• University of British Columbia: collaborator
• University of Calgary: collaborator
• Dalhousie University: collaborator
• University of Manitoba: collaborator
• University of Toronto: collaborator
• University of Alberta: collaborator

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

RECRUITING

Related Publications (53)

• Keeling SO, Alabdurubalnabi Z, Avina-Zubieta A, Barr S, Bergeron L, Bernatsky S, Bourre-Tessier J, Clarke A, Baril-Dionne A, Dutz J, Ensworth S, Fifi-Mah A, Fortin PR, Gladman DD, Haaland D, Hanly JG, Hiraki LT, Hussein S, Legault K, Levy D, Lim L, Matsos M, McDonald EG, Medina-Rosas J, Pardo Pardi J, Peschken C, Pineau C, Pope J, Rader T, Reynolds J, Silverman E, Tselios K, Suitner M, Urowitz M, Touma Z, Vinet E, Santesso N. Canadian Rheumatology Association Recommendations for the Assessment and Monitoring of Systemic Lupus Erythematosus. J Rheumatol. 2018 Oct;45(10):1426-1439. doi: 10.3899/jrheum.171459. Epub 2018 Sep 1.

  PMID: 30173152 BACKGROUND

• Jonsen A, Clarke AE, Joseph L, Belisle P, Bernatsky S, Nived O, Bengtsson AA, Sturfelt G, Pineau CA. Association of the Charlson comorbidity index with mortality in systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2011 Sep;63(9):1233-7. doi: 10.1002/acr.20506.

  PMID: 21618451 BACKGROUND

• Akhavan PS, Su J, Lou W, Gladman DD, Urowitz MB, Fortin PR. The early protective effect of hydroxychloroquine on the risk of cumulative damage in patients with systemic lupus erythematosus. J Rheumatol. 2013 Jun;40(6):831-41. doi: 10.3899/jrheum.120572. Epub 2013 Apr 15.

  PMID: 23588942 BACKGROUND

• Levy DM, Peschken CA, Tucker LB, Chedeville G, Huber AM, Pope JE; Canadian Network for Improved Outcomes in SLE (CaNIOS) 1000 Faces Investigators; Silverman ED. Association of health-related quality of life in childhood-onset systemic lupus erythematosus with ethnicity: results from a multiethnic multicenter Canadian cohort. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1767-74. doi: 10.1002/acr.22363.

  PMID: 24821613 BACKGROUND

• Aghdassi E, Zhang W, St-Pierre Y, Clarke AE, Morrison S, Peeva V, Landolt-Marticorena C, Su J, Reich H, Scholey J, Herzenberg A, Pope JE, Peschken C; LuNNET CaNIOS Investigators; Wither JE, Fortin PR. Healthcare cost and loss of productivity in a Canadian population of patients with and without lupus nephritis. J Rheumatol. 2011 Apr;38(4):658-66. doi: 10.3899/jrheum.100482. Epub 2010 Dec 15.

  PMID: 21159829 BACKGROUND

• Peschken CA, Katz SJ, Silverman E, Pope JE, Fortin PR, Pineau C, Smith CD, Arbillaga HO, Gladman DD, Urowitz M, Zummer M, Clarke A, Bernatsky S, Hudson M; Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS). The 1000 Canadian faces of lupus: determinants of disease outcome in a large multiethnic cohort. J Rheumatol. 2009 Jun;36(6):1200-8. doi: 10.3899/jrheum.080912. Epub 2009 Apr 15.

  PMID: 19369456 BACKGROUND

• Bruce IN, O'Keeffe AG, Farewell V, Hanly JG, Manzi S, Su L, Gladman DD, Bae SC, Sanchez-Guerrero J, Romero-Diaz J, Gordon C, Wallace DJ, Clarke AE, Bernatsky S, Ginzler EM, Isenberg DA, Rahman A, Merrill JT, Alarcon GS, Fessler BJ, Fortin PR, Petri M, Steinsson K, Dooley MA, Khamashta MA, Ramsey-Goldman R, Zoma AA, Sturfelt GK, Nived O, Aranow C, Mackay M, Ramos-Casals M, van Vollenhoven RF, Kalunian KC, Ruiz-Irastorza G, Lim S, Kamen DL, Peschken CA, Inanc M, Urowitz MB. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort. Ann Rheum Dis. 2015 Sep;74(9):1706-13. doi: 10.1136/annrheumdis-2013-205171. Epub 2014 May 16.

  PMID: 24834926 BACKGROUND

• Lee J, Dhillon N, Pope J. All-cause hospitalizations in systemic lupus erythematosus from a large Canadian referral centre. Rheumatology (Oxford). 2013 May;52(5):905-9. doi: 10.1093/rheumatology/kes391. Epub 2013 Jan 9.

  PMID: 23307831 BACKGROUND

• Garcia-Gonzalez A, Richardson M, Garcia Popa-Lisseanu M, Cox V, Kallen MA, Janssen N, Ng B, Marcus DM, Reveille JD, Suarez-Almazor ME. Treatment adherence in patients with rheumatoid arthritis and systemic lupus erythematosus. Clin Rheumatol. 2008 Jul;27(7):883-9. doi: 10.1007/s10067-007-0816-6. Epub 2008 Jan 8.

  PMID: 18185905 BACKGROUND

• Koneru S, Kocharla L, Higgins GC, Ware A, Passo MH, Farhey YD, Mongey AB, Graham TB, Houk JL, Brunner HI. Adherence to medications in systemic lupus erythematosus. J Clin Rheumatol. 2008 Aug;14(4):195-201. doi: 10.1097/RHU.0b013e31817a242a.

  PMID: 18636020 BACKGROUND

• Mehat P, Atiquzzaman M, Esdaile JM, AviNa-Zubieta A, De Vera MA. Medication Nonadherence in Systemic Lupus Erythematosus: A Systematic Review. Arthritis Care Res (Hoboken). 2017 Nov;69(11):1706-1713. doi: 10.1002/acr.23191. Epub 2017 Sep 21.

  PMID: 28086003 BACKGROUND

• Leroux G, Costedoat-Chalumeau N, Hulot JS, Amoura Z, Frances C, Aymard G, Lechat P, Piette JC. Relationship between blood hydroxychloroquine and desethylchloroquine concentrations and cigarette smoking in treated patients with connective tissue diseases. Ann Rheum Dis. 2007 Nov;66(11):1547-8. doi: 10.1136/ard.2007.072587. No abstract available.

  PMID: 17934086 BACKGROUND

• Dixon WG, Abrahamowicz M, Beauchamp ME, Ray DW, Bernatsky S, Suissa S, Sylvestre MP. Immediate and delayed impact of oral glucocorticoid therapy on risk of serious infection in older patients with rheumatoid arthritis: a nested case-control analysis. Ann Rheum Dis. 2012 Jul;71(7):1128-33. doi: 10.1136/annrheumdis-2011-200702. Epub 2012 Jan 12.

  PMID: 22241902 BACKGROUND

• Widdifield J, Moura CS, Wang Y, Abrahamowicz M, Paterson JM, Huang A, Beauchamp ME, Boire G, Fortin PR, Bessette L, Bombardier C, Hanly JG, Feldman D, Bernatsky S; CAnadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CAN-AIM). The Longterm Effect of Early Intensive Treatment of Seniors with Rheumatoid Arthritis: A Comparison of 2 Population-based Cohort Studies on Time to Joint Replacement Surgery. J Rheumatol. 2016 May;43(5):861-8. doi: 10.3899/jrheum.151156. Epub 2016 Feb 15.

  PMID: 26879353 BACKGROUND

• Moura CS, Abrahamowicz M, Beauchamp ME, Lacaille D, Wang Y, Boire G, Fortin PR, Bessette L, Bombardier C, Widdifield J, Hanly JG, Feldman D, Maksymowych W, Peschken C, Barnabe C, Edworthy S, Bernatsky S; CAN-AIM. Early medication use in new-onset rheumatoid arthritis may delay joint replacement: results of a large population-based study. Arthritis Res Ther. 2015 Aug 3;17(1):197. doi: 10.1186/s13075-015-0713-3.

  PMID: 26235697 BACKGROUND

• Sylvestre MP, Abrahamowicz M. Flexible modeling of the cumulative effects of time-dependent exposures on the hazard. Stat Med. 2009 Nov 30;28(27):3437-53. doi: 10.1002/sim.3701.

  PMID: 19708037 BACKGROUND

• Marmor MF, Carr RE, Easterbrook M, Farjo AA, Mieler WF; American Academy of Ophthalmology. Recommendations on screening for chloroquine and hydroxychloroquine retinopathy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002 Jul;109(7):1377-82. doi: 10.1016/s0161-6420(02)01168-5. No abstract available.

  PMID: 12093666 BACKGROUND

• Sun X, Li X, Chen C, Song Y. A review of statistical issues with progression-free survival as an interval-censored time-to-event endpoint. J Biopharm Stat. 2013;23(5):986-1003. doi: 10.1080/10543406.2013.813524.

  PMID: 23957511 BACKGROUND

• Wynant W, Abrahamowicz M. Flexible estimation of survival curves conditional on non-linear and time-dependent predictor effects. Stat Med. 2016 Feb 20;35(4):553-65. doi: 10.1002/sim.6740. Epub 2015 Nov 6.

  PMID: 26542758 BACKGROUND

• Wynant W, Abrahamowicz M. Impact of the model-building strategy on inference about nonlinear and time-dependent covariate effects in survival analysis. Stat Med. 2014 Aug 30;33(19):3318-37. doi: 10.1002/sim.6178. Epub 2014 Apr 22.

  PMID: 24757068 BACKGROUND

• Reed Johnson F, Lancsar E, Marshall D, Kilambi V, Muhlbacher A, Regier DA, Bresnahan BW, Kanninen B, Bridges JF. Constructing experimental designs for discrete-choice experiments: report of the ISPOR Conjoint Analysis Experimental Design Good Research Practices Task Force. Value Health. 2013 Jan-Feb;16(1):3-13. doi: 10.1016/j.jval.2012.08.2223.

  PMID: 23337210 BACKGROUND

• Black N, Burke L, Forrest CB, Sieberer UH, Ahmed S, Valderas JM, Bartlett SJ, Alonso J. Patient-reported outcomes: pathways to better health, better services, and better societies. Qual Life Res. 2016 May;25(5):1103-12. doi: 10.1007/s11136-015-1168-3. Epub 2015 Nov 13.

  PMID: 26563251 BACKGROUND

• Neville C, DaCosta D, Rochon M, Eng D, Fortin PR. Toward the development of a lupus interactive navigator to facilitate patients and their health care providers in the management of lupus: results of web-based surveys. JMIR Res Protoc. 2014 Dec 22;3(4):e65. doi: 10.2196/resprot.3349.

  PMID: 25533760 BACKGROUND

• Bernatsky S, Peschken C, Fortin PR, Pineau CA, Urowitz MB, Gladman DD, Pope JE, Hudson M, Zummer M, Smith CD, Arbillaga HO, Clarke AE; Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS). Medication use in systemic lupus erythematosus. J Rheumatol. 2011 Feb;38(2):271-4. doi: 10.3899/jrheum.100414. Epub 2010 Nov 15.

  PMID: 21078722 BACKGROUND

• Clarke AE, Urowitz MB, Monga N, Hanly JG. Costs associated with severe and nonsevere systemic lupus erythematosus in Canada. Arthritis Care Res (Hoboken). 2015 Mar;67(3):431-6. doi: 10.1002/acr.22452.

  PMID: 25185936 BACKGROUND

• Mahler M, Parker T, Peebles CL, Andrade LE, Swart A, Carbone Y, Ferguson DJ, Villalta D, Bizzaro N, Hanly JG, Fritzler MJ. Anti-DFS70/LEDGF antibodies are more prevalent in healthy individuals compared to patients with systemic autoimmune rheumatic diseases. J Rheumatol. 2012 Nov;39(11):2104-10. doi: 10.3899/jrheum.120598. Epub 2012 Sep 1.

  PMID: 22942262 BACKGROUND

• Furst DE, Clarke A, Fernandes AW, Bancroft T, Gajria K, Greth W, Iorga SR. Resource utilization and direct medical costs in adult systemic lupus erythematosus patients from a commercially insured population. Lupus. 2013 Mar;22(3):268-78. doi: 10.1177/0961203312474087. Epub 2013 Jan 22.

  PMID: 23340996 BACKGROUND

• Isenberg DA, Gladman D. The Systemic Lupus International Collaborating Clinics Group--origins and outcomes. Lupus. 2001;10(5):375-7. doi: 10.1191/096120301676101377. No abstract available.

  PMID: 11403271 BACKGROUND

• Isenberg DA, Ramsey-Goldman R, Gladman D, Hanly JG. The Systemic Lupus International Collaborating Clinics (SLICC) group - it was 20 years ago today. Lupus. 2011 Nov;20(13):1426-32. doi: 10.1177/0961203311421501.

  PMID: 22095889 BACKGROUND

• Lee J, Peschken CA, Muangchan C, Silverman E, Pineau C, Smith CD, Arbillaga H, Zummer M, Clarke A, Bernatsky S, Hudson M, Hitchon C, Fortin PR, Pope JE. The frequency of and associations with hospitalization secondary to lupus flares from the 1000 Faces of Lupus Canadian cohort. Lupus. 2013 Nov;22(13):1341-8. doi: 10.1177/0961203313505689. Epub 2013 Sep 18.

  PMID: 24048215 BACKGROUND

• Bernatsky S, Ramsey-Goldman R, Labrecque J, Joseph L, Boivin JF, Petri M, Zoma A, Manzi S, Urowitz MB, Gladman D, Fortin PR, Ginzler E, Yelin E, Bae SC, Wallace DJ, Edworthy S, Jacobsen S, Gordon C, Dooley MA, Peschken CA, Hanly JG, Alarcon GS, Nived O, Ruiz-Irastorza G, Isenberg D, Rahman A, Witte T, Aranow C, Kamen DL, Steinsson K, Askanase A, Barr S, Criswell LA, Sturfelt G, Patel NM, Senecal JL, Zummer M, Pope JE, Ensworth S, El-Gabalawy H, McCarthy T, Dreyer L, Sibley J, St Pierre Y, Clarke AE. Cancer risk in systemic lupus: an updated international multi-centre cohort study. J Autoimmun. 2013 May;42:130-5. doi: 10.1016/j.jaut.2012.12.009. Epub 2013 Feb 12.

  PMID: 23410586 BACKGROUND

• Bernatsky S, Ramsey-Goldman R, Joseph L, Boivin JF, Costenbader KH, Urowitz MB, Gladman DD, Fortin PR, Nived O, Petri MA, Jacobsen S, Manzi S, Ginzler EM, Isenberg D, Rahman A, Gordon C, Ruiz-Irastorza G, Yelin E, Bae SC, Wallace DJ, Peschken CA, Dooley MA, Edworthy SM, Aranow C, Kamen DL, Romero-Diaz J, Askanase A, Witte T, Barr SG, Criswell LA, Sturfelt GK, Blanco I, Feldman CH, Dreyer L, Patel NM, St Pierre Y, Clarke AE. Lymphoma risk in systemic lupus: effects of disease activity versus treatment. Ann Rheum Dis. 2014 Jan;73(1):138-42. doi: 10.1136/annrheumdis-2012-202099. Epub 2013 Jan 8.

  PMID: 23303389 BACKGROUND

• Bernatsky S, Clarke A, Gladman DD, Urowitz M, Fortin PR, Barr SG, Senecal JL, Zummer M, Edworthy S, Sibley J, Pope J, Ensworth S, Ramsey-Goldman R, Hanly JG. Mortality related to cerebrovascular disease in systemic lupus erythematosus. Lupus. 2006;15(12):835-9. doi: 10.1177/0961203306073133.

  PMID: 17211987 BACKGROUND

• Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.

  PMID: 16868977 BACKGROUND

• Lu M, Bernatsky S, Ramsey-Goldman R, Petri M, Manzi S, Urowitz MB, Gladman D, Fortin PR, Ginzler EM, Yelin E, Bae SC, Wallace DJ, Jacobsen S, Dooley MA, Peschken CA, Alarcon GS, Nived O, Gottesman L, Criswell LA, Sturfelt G, Dreyer L, Lee JL, Clarke AE. Non-lymphoma hematological malignancies in systemic lupus erythematosus. Oncology. 2013;85(4):235-40. doi: 10.1159/000350165. Epub 2013 Oct 2.

  PMID: 24107608 BACKGROUND

• Steiner JF, Koepsell TD, Fihn SD, Inui TS. A general method of compliance assessment using centralized pharmacy records. Description and validation. Med Care. 1988 Aug;26(8):814-23. doi: 10.1097/00005650-198808000-00007.

  PMID: 3398608 BACKGROUND

• Bernatsky S, Joseph L, Pineau CA, Tamblyn R, Feldman DE, Clarke AE. A population-based assessment of systemic lupus erythematosus incidence and prevalence--results and implications of using administrative data for epidemiological studies. Rheumatology (Oxford). 2007 Dec;46(12):1814-8. doi: 10.1093/rheumatology/kem233.

  PMID: 18032538 RESULT

• Canadian Hydroxychloroquine Study Group. A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus. N Engl J Med. 1991 Jan 17;324(3):150-4. doi: 10.1056/NEJM199101173240303.

  PMID: 1984192 RESULT

• Tsakonas E, Joseph L, Esdaile JM, Choquette D, Senecal JL, Cividino A, Danoff D, Osterland CK, Yeadon C, Smith CD. A long-term study of hydroxychloroquine withdrawal on exacerbations in systemic lupus erythematosus. The Canadian Hydroxychloroquine Study Group. Lupus. 1998;7(2):80-5. doi: 10.1191/096120398678919778.

  PMID: 9541091 RESULT

• Waldron N, Brown S, Hewlett S, Elliott B, McHugh N, McCabe C. 'It's more scary not to know': a qualitative study exploring the information needs of patients with systemic lupus erythematosus at the time of diagnosis. Musculoskeletal Care. 2011 Dec;9(4):228-38. doi: 10.1002/msc.221. Epub 2011 Oct 13.

  PMID: 21993962 RESULT

• Telek HH, Yesilirmak N, Sungur G, Ozdemir Y, Yesil NK, Ornek F. Retinal toxicity related to hydroxychloroquine in patients with systemic lupus erythematosus and rheumatoid arthritis. Doc Ophthalmol. 2017 Dec;135(3):187-194. doi: 10.1007/s10633-017-9607-9. Epub 2017 Aug 29.

  PMID: 28852896 RESULT

• Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, Bacon P, Bombardieri S, Hanly J, Hay E, Isenberg D, Jones J, Kalunian K, Maddison P, Nived O, Petri M, Richter M, Sanchez-Guerrero J, Snaith M, Sturfelt G, Symmons D, Zoma A. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996 Mar;39(3):363-9. doi: 10.1002/art.1780390303.

  PMID: 8607884 RESULT

• Yee CS, Farewell VT, Isenberg DA, Griffiths B, Teh LS, Bruce IN, Ahmad Y, Rahman A, Prabu A, Akil M, McHugh N, Edwards C, D'Cruz D, Khamashta MA, Gordon C. The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients. Rheumatology (Oxford). 2011 May;50(5):982-8. doi: 10.1093/rheumatology/keq376. Epub 2011 Jan 18.

  PMID: 21245073 RESULT

• Ward MM, Marx AS, Barry NN. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol. 2000 Mar;27(3):664-70.

  PMID: 10743805 RESULT

• Satagopan JM, Ben-Porat L, Berwick M, Robson M, Kutler D, Auerbach AD. A note on competing risks in survival data analysis. Br J Cancer. 2004 Oct 4;91(7):1229-35. doi: 10.1038/sj.bjc.6602102.

  PMID: 15305188 RESULT

• Hazlewood GS, Bombardier C, Tomlinson G, Thorne C, Bykerk VP, Thompson A, Tin D, Marshall DA. Treatment preferences of patients with early rheumatoid arthritis: a discrete-choice experiment. Rheumatology (Oxford). 2016 Nov;55(11):1959-1968. doi: 10.1093/rheumatology/kew280. Epub 2016 Jul 31.

  PMID: 27477807 RESULT

• Petri M, Genovese M, Engle E, Hochberg M. Definition, incidence, and clinical description of flare in systemic lupus erythematosus. A prospective cohort study. Arthritis Rheum. 1991 Aug;34(8):937-44. doi: 10.1002/art.1780340802.

  PMID: 1859487 RESULT

• Hoaglin DC, Hawkins N, Jansen JP, Scott DA, Itzler R, Cappelleri JC, Boersma C, Thompson D, Larholt KM, Diaz M, Barrett A. Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 2. Value Health. 2011 Jun;14(4):429-37. doi: 10.1016/j.jval.2011.01.011.

  PMID: 21669367 RESULT

• Haase KR, Loiselle CG. Oncology team members' perceptions of a virtual navigation tool for cancer patients. Int J Med Inform. 2012 Jun;81(6):395-403. doi: 10.1016/j.ijmedinf.2011.11.001. Epub 2012 Jan 13.

  PMID: 22244817 RESULT

• Loiselle CG, Peters O, Haase KR, Girouard L, Korner A, Wiljer D, Fitch M. Virtual navigation in colorectal cancer and melanoma: an exploration of patients' views. Support Care Cancer. 2013 Aug;21(8):2289-96. doi: 10.1007/s00520-013-1771-1. Epub 2013 Mar 22.

  PMID: 23519565 RESULT

• Neville C, Da Costa D, Rochon M, Peschken CA, Pineau CA, Bernatsky S, Keeling S, Avina-Zubieta A, Lye E, Eng D, Fortin PR. Development of the Lupus Interactive Navigator as an Empowering Web-Based eHealth Tool to Facilitate Lupus Management: Users Perspectives on Usability and Acceptability. JMIR Res Protoc. 2016 May 30;5(2):e44. doi: 10.2196/resprot.4219.

  PMID: 27240666 RESULT

• Moss KE, Ioannou Y, Sultan SM, Haq I, Isenberg DA. Outcome of a cohort of 300 patients with systemic lupus erythematosus attending a dedicated clinic for over two decades. Ann Rheum Dis. 2002 May;61(5):409-13. doi: 10.1136/ard.61.5.409.

  PMID: 11959764 RESULT

• Clowse ME, Magder L, Witter F, Petri M. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum. 2006 Nov;54(11):3640-7. doi: 10.1002/art.22159.

  PMID: 17075810 RESULT

Related Links

• AAO Quality of Care Secretariat, Hoskins Center for Quality Eye Care Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy Ophthalmology
• CAnadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research
• Lack of Interferon and Proinflammatory Cyto/chemokines in Serologically Active Clinically Quiescent SLE.
• Racial and Ethnic Categories and Definitions
• Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Administration and policy in mental health
• Patient Reported Outcomes in Rheumatic Diseases, Rheumatic Disease Clinics of North America

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sasha Bernatsky, MD/PhD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lee

CONTACT

514-934-1934; Jennifer.Lee@rimuhc.ca

Autumn Neville

CONTACT

514-934-1934; autumn.neville@rimuch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: January 14, 2019
• Study Start: May 9, 2018
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)