|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01305746 |
|
Date of registration:
|
25/02/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
|
|
Scientific title:
|
An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC) |
|
Date of first enrolment:
|
April 2011 |
|
Target sample size:
|
382 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01305746 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Argentina
|
Brazil
|
Chile
|
Colombia
|
Hong Kong
|
India
|
Mexico
|
Peru
|
|
Philippines
|
Taiwan
|
United States
| | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Completed the treatment period specified in study AN-SLE3321 or were enrolled in
study AN-SLE3321 prior to November 30, 2010
Exclusion Criteria:
- Developed a new medical disease or condition that has made the subject unsuitable for
this study in the opinion of the Investigator, including interference with written
informed consent, study evaluation, completion, and/or procedures
- Pregnant or nursing
- Any prior administration of a B-cell modulating therapy other than A-623
- Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion,
plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to
listed wash-out periods
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Systemic Lupus Erythematosus
|
|
Intervention(s)
|
|
Drug: A-623
|
|
Primary Outcome(s)
|
|
To assess the long term safety of A-623 in subjects with SLE
[Time Frame: Until the drug is approved or the Sponsor discontinues the study]
|
|
Secondary ID(s)
|
|
AN-SLE3322
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|