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A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843125
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Baricitinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally.
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104
Experimental: Baricitinib Low Dose
Baricitinib administered orally.
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with TEAEs

  2. Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline through Week 156 ]
    Percentage of Participants with AESIs

  3. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with SAEs

  4. Percentage of Participants with Temporary Investigational Product Interruptions [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with temporary investigational product interruptions

  5. Percentage of Participants with Permanent Investigational Product Discontinuations [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with permanent investigational product discontinuations


Secondary Outcome Measures :
  1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response [ Time Frame: Week 156 ]
    Percentage of participants achieving SRI-4 response

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 156 ]
    Percentage of participants achieving a LLDAS

  3. Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 156 ]
    Change from baseline in prednisone dose

  4. Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate [ Time Frame: Baseline through Week 156 ]
    Annualized SELENA-SLEDAI flare index flare rate

  5. Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI Total Activity Score [ Time Frame: Week 156 ]
    Percentage of participants with CLASI total activity score ≥10 at baseline with ≥50% reduction in CLASI total activity score

  6. Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 156 ]
    Change from baseline in tender joint count

  7. Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 156 ]
    Change from baseline in swollen joint count

  8. Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score [ Time Frame: Baseline, Week 156 ]
    Change from baseline in SLICC/ACR damage index total score

  9. Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 156 ]
    Change from baseline in worst pain NRS


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
Contacts and Locations
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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): NCT03843125


Contacts
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Contact: There may be multiples sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)  This link exits the ClinicalTrials.gov site

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03843125    
Other Study ID Numbers: 16832
I4V-MC-JAIM ( Other Identifier: Eli Lilly and Company )
2017-005028-11 ( EudraCT Number )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases