NCT00413361

Brief Summary

The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 27, 2011

Status Verified

May 1, 2007

Enrollment Period

3.6 years

First QC Date

December 18, 2006

Last Update Submit

January 26, 2011

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus ErythematosusHydroxychloroquine

Outcome Measures

Primary Outcomes (1)

  • The number of patient in each group who developed a flare (according to the SELENA-SLEDAI composite criteria) during the study period.

    The number of patient in each group who developed a flare (according to the SELENA-SLEDAI composite criteria) during the study period.

    7 months of follow up

Secondary Outcomes (7)

  • The number of patients in each group who developed a flare during the study period.

    7 months of follow up

  • The total number of flares in each group

    7 months of follow up

  • the total dose of steroids in each group

    7 months of follow up

  • the area under the curve of SELENA SLEDAI in each group

    7 months of follow up

  • the mean change of the quality of life questionnaire SF-36

    7 months of follow up

  • +2 more secondary outcomes

Study Arms (2)

A

PLACEBO COMPARATOR

placebo

Drug: versus hydroxychloroquine

B

EXPERIMENTAL

versus hydroxychloroquine

Drug: versus hydroxychloroquine

Interventions

versus hydroxychloroquineDRUG

versus hydroxychloroquine

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 and above
  • Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria.
  • Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 months
  • Stable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day)
  • No increase in the steroids dosage during the 3 previous weeks
  • Steroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalent
  • No modifications of a possible immunosuppressor during the 2 previous months
  • SELENA-SLEDAI \< or = 12
  • Signature of the consent of participation

You may not qualify if:

  • Known retinopathy, present or passed
  • Severe cataract obstructing the ophthalmologic monitoring
  • MONOPHTALM patients
  • Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage
  • Use of nivaquine during the 3 previous months
  • Treatment with biotherapy (for example Rituximab) during the 12 previous months
  • Calculated clearance of creatinin lower than 60 ml/min
  • Chronic alcoholism
  • Liver failure
  • Desire of pregnancy in the next 7 months
  • Known non compliance, and risks of random follow-up
  • Absence of social security cover
  • People profiting from a particular protection:
  • Pregnant women
  • Age under 18
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu Pitie Salpetriere

Paris, 75013, France

Location

Hopital la Pitié Salpétrière Assistance Publique

Paris, 75013, France

Location

Related Publications (4)

  • Morris DL, Sheng Y, Zhang Y, Wang YF, Zhu Z, Tombleson P, Chen L, Cunninghame Graham DS, Bentham J, Roberts AL, Chen R, Zuo X, Wang T, Wen L, Yang C, Liu L, Yang L, Li F, Huang Y, Yin X, Yang S, Ronnblom L, Furnrohr BG, Voll RE, Schett G, Costedoat-Chalumeau N, Gaffney PM, Lau YL, Zhang X, Yang W, Cui Y, Vyse TJ. Genome-wide association meta-analysis in Chinese and European individuals identifies ten new loci associated with systemic lupus erythematosus. Nat Genet. 2016 Aug;48(8):940-946. doi: 10.1038/ng.3603. Epub 2016 Jul 11.

    PMID: 27399966DERIVED

  • Schoindre Y, Jallouli M, Tanguy ML, Ghillani P, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Le Thi Huong D, Asli B, Kahn JE, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Leroux G, Cohen-Bittan J, Hulot JS, Lechat P, Musset L, Piette JC, Amoura Z, Souberbielle JC, Costedoat-Chalumeau N; Group PLUS. Lower vitamin D levels are associated with higher systemic lupus erythematosus activity, but not predictive of disease flare-up. Lupus Sci Med. 2014 Jun 7;1(1):e000027. doi: 10.1136/lupus-2014-000027. eCollection 2014.

    PMID: 25379192DERIVED

  • Morel N, Bachelot A, Chakhtoura Z, Ghillani-Dalbin P, Amoura Z, Galicier L, Aumaitre O, Piette JC, Pourrat J, Boutin D, Sacre K, Kahn JE, Duhaut P, Farge D, Frances C, Guettrot-Imbert G, Harle JR, Lambotte O, Le Guern V, Sene D, Trad S, Vidal E, Sarrot-Reynauld F, Gompel A, Tanguy ML, Touraine P, Lacorte JM, Costedoat-Chalumeau N; PLUS group. Study of anti-Mullerian hormone and its relation to the subsequent probability of pregnancy in 112 patients with systemic lupus erythematosus, exposed or not to cyclophosphamide. J Clin Endocrinol Metab. 2013 Sep;98(9):3785-92. doi: 10.1210/jc.2013-1235. Epub 2013 Jul 5.

    PMID: 23833039DERIVED

  • Costedoat-Chalumeau N, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.

    PMID: 23144449DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nathalie COSTEDOAT-CHALUMEAU, MD,

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

June 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 27, 2011

Record last verified: 2007-05

Locations

FR(2)