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Trial record 38 of 134 for:    Lupus AND (woman OR women OR female)

Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region (APLCLLDAS)

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ClinicalTrials.gov Identifier: NCT03138941
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Flinders Medical Centre, Adelaide, AUSTRALIA
St. Vincent's Hospital, Melbourne, AUSTRALIA
Royal Adelaide Hospital, Adelaide, AUSTRALIA
University of New South Wales, Sydney, AUSTRALIA
People's Hospital, Peking University Health Science Center, Beijing, CHINA
Peking University First Hospital, Beijing, CHINA
The University of Hong Kong, HONG KONG
University of Padjadjaran, Bandung, INDONESIA
Tokyo Women's Medical University, JAPAN
University of Occupational and Environmental Health, JAPAN
Keio University, JAPAN
Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA
University of Malaya
University of Santo Tomas Hospital, Philippines
National University Hospital, Singapore
Tan Tock Seng Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
Chiang Mai University Hospital, THAILAND
Dubai Hospital, Dubai, UNITED ARAB EMIRATES
Middlemore Hospital, New Zealand
North Shore Hospital, Auckland, NEW ZEALAND
Auckland District Health Board, Auckland, NEW ZEALAND
Information provided by (Responsible Party):
Eric F Morand, Monash University

Brief Summary:

Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE).

SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time.

The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease.

In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.


Condition or disease
Systemic Lupus Erythematosus

Detailed Description:

In this study, patients with SLE will be followed for ~ 5 years. Regular recordings of the data needed to score LLDAS (disease activity and treatment domains, see Franklyn L et al, Ann Rheum Dis 2016) will be collected, as well as annual recording of lupus-related damage using the SLICC_ACR Damage Index (SDI) and quality of life using the Short Form 36 version 2 (SF36v2).

At conclusion of primary data collection, the associate of LLDAS attainment, or sustained attainment, with protection from organ damage accrual will be ascertained.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
Actual Study Start Date : September 1, 2013
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. SLICC-ACR Damage Index [ Time Frame: Up to 5 years ]
    Organ damage accrual


Secondary Outcome Measures :
  1. SFv2-36 [ Time Frame: Up to 5 years ]
    Quality of Life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult SLE patients with confirmed lupus
Criteria

Inclusion Criteria:

  • All patients have to meet either the 1997 American College of Rheumatology (ACR) Modified Classification Criteria for SLE, with at least four of the 11 items; or alternatively, fulfil the Systemic Lupus International Collaborating Clinics (SLICC) 2012 Classification Criteria, with at least four of the 17 items (at least one clinical and one immunological criterion) or with lupus nephritis in the presence of at least one immunological criteria. Patients can be either newly diagnosed or longstanding lupus patients.

All patients must be over the age of 18 and competent to provide written consent.

Exclusion Criteria:

  • Patients less than 18 years of age and patients who are unable to consent are excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138941


Contacts
Contact: Eric F Morand + 61 3 8572 2650 eric.morand@monash.edu
Contact: Rangi K KANDANE-RATHNAYAKE + 61 3 8572 2561 Rangi.Kandane-Rathnayake@monash.edu

  Show 21 Study Locations
Sponsors and Collaborators
Monash University
Flinders Medical Centre, Adelaide, AUSTRALIA
St. Vincent's Hospital, Melbourne, AUSTRALIA
Royal Adelaide Hospital, Adelaide, AUSTRALIA
University of New South Wales, Sydney, AUSTRALIA
People's Hospital, Peking University Health Science Center, Beijing, CHINA
Peking University First Hospital, Beijing, CHINA
The University of Hong Kong, HONG KONG
University of Padjadjaran, Bandung, INDONESIA
Tokyo Women's Medical University, JAPAN
University of Occupational and Environmental Health, JAPAN
Keio University, JAPAN
Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA
University of Malaya
University of Santo Tomas Hospital, Philippines
National University Hospital, Singapore
Tan Tock Seng Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
Chiang Mai University Hospital, THAILAND
Dubai Hospital, Dubai, UNITED ARAB EMIRATES
Middlemore Hospital, New Zealand
North Shore Hospital, Auckland, NEW ZEALAND
Auckland District Health Board, Auckland, NEW ZEALAND
Investigators
Study Chair: Eric Morand Monash University

Additional Information:
Publications:

Responsible Party: Eric F Morand, Professor of Medicine; Head, School of Clinical Sciences at Monash Health, Monash University;DIrector, Rheumatology, Monash Health, Monash University
ClinicalTrials.gov Identifier: NCT03138941     History of Changes
Other Study ID Numbers: APLC LLDAS Study
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data collected and collated by the Asia Pacific Lupus Collaboration (APLC) is guided by strict protocols and procedures to ensure that privacy and other ethical principles are maintained at all times. Data sharing will strictly follows the APLC Data Access Policy. Under no circumstances will individual subject data be made available to any third parties.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases