Status:
COMPLETED
International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
6-80 years
Brief Summary
The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. How...
Detailed Description
This international multicentric prospective study is an observational study that will include consecutive SLE patients treated with HCQ and with SLE flare (defined by the SELENA-SLEDAI flare composite...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- History of meeting 4 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus including a positive test for antinuclear antibodies,
- SLE flare defined by the SELENA-SLEDAI flare composite
- Treatment with HCQ for at least 2 months with a daily dosage \> or equal to 200 mg/day.
- Exclusion criteria :
- Patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT01509989
Start Date
January 1 2013
End Date
March 1 2016
Last Update
July 6 2016
Active Locations (1)
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1
Hopital Cochin
Paris, France, 75679