A PHASE 2B, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SIFALIMUMAB IN ADULTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Not Applicable

• Registration Number: PER-044-11
• Lead Sponsor: ASTRAZENECA PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1) IN THE OPINION OF THE INVESTIGATOR, MUST HAVE ADEQUATE READING AND WRITTING ABILITIES (IN THEIR NATIVE LANGUAGE) SUCH THAT THE SUBJECT CAN COMPREHEND AND COMPLETE THE INFORMED CONSENT, AND ALL PROTOCOL-RELATED SUBJECT ASSESSMENT.
2) AGE 18-75 YEARS AT THE TIME OF SCREENING.
3) WRITTEN INFORMED CONSENT AND ANY LOCALLY REQUIRED AUTHORIZATION (eg, HIPAA IN THE USA, DATA PRIVACY DIRECTIVE IN THE EU) OBTAINED FROM THE SUBJECT PRIOR TO PERFORMING ANY PROTOCOL-RELATED PROCEDURES, INCLUDING SCREENING EVALUATIONS.
4) FULFILS AT LEAST 4 OF THE 11 AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CLASSIFICATION CRITERIA FOR SLE (SEE APPENDIX 2), ONE OF WHICH MUST BE:
A) SIGNIFICANTLY POSITIVE ANTINUCLEAR ANTIBODY (ANA) TEST AT SCREENING BY IMMUNOFLUORESCENT ASSAY (IFA) AT CENTRAL LAB; OR
B) ELEVATED ANTI-DSDNA OR SM ANTIBODY AT SCREENING AS DETERMINED BY CENTRAL LAB.
5) WEIGHT ≥ 40.0 KG AT SCREENING.
6) DIAGNOSIS OF PEDIATRIC OR ADULT SLE WITH CHRONIC DISEASE ACTIVITY REQUIRING ONGOING TREATMENT OBSERVATION FOR ≥ 24 (≥ 168 DAYS) PRIOR TO SCREENING.

Exclusion Criteria

1) ANY CONDITION THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD INTERFERE WITH EVALUATION OF THE INVESTIGATIONAL PRODUCT OR CONFOUND INTERPRETATION OF SUBJECT SAFETY OR STUDY RESULTS.
2) CONCURRENT ENROLLMENT IN ANY OTHER CLINICAL STUDY WITH AN INVESTIGATIONAL PRODUCT WHITIN 4 WEEKS (28 DAYS) PRIO TO DAY 1 OR WITHIN 5 HALF-LIVES OF THE INVESTIGATIONALIN PRODUCT USED IN THAT CLINICAL STUDY, WHICHEVER IS LONGER.
3) EMPLOYEES OF THE CLINICAL STUDY SITE OR ANY OTHER INDIVIDUALS INVOLVED WITH THE CONDUCT OF THE STUDY OR IMMEDIATE FAMILY MEMBERS OF SUCH INDIVIDUALS.
4) RECEIPT OF ANY OF THE FOLLOWING:
A) ANY NEW ORAL PREDNISONE THERAPY (OR EQUIVALENT) OR ANY CHANGE IN CURRENT ORAL PREDNISONE DOSE (OR EQUIVALENT) ANYTIME FROM 2 WEEKS (14 DAYS) PRIOR TO SIGNING OF THE INFORMED CONSENT THROUGH DAY 1 (SEE TABLE 4.2.1-1 FOR EXAMPLES OF PRENISONE EQUIVALENCY).
B) ANY NEW DOSE OR CHANGE IN CURRENT DOSE OF ANY OF THE FOLLOWING ANYTIME IN THE 8 WEEKS (56 DAYS) PRIOR TO SIGNING OF THE INFORMED CONSENT THROUGH DAY 1: AZATHIOPRINE; ANY ANTIMALARIAL (eg, CHLOROQUINE, HYDROXYCHLOROQUINE, QUINACRINE); MYCOPHENOLATE MOFETIL/MYCOPHENOLIC ACID; ORAL OR METHOTREXATE; OR SC METHOTREXATE. 

Study & Design

• Study Type: Interventional
• Study Design: Not specified