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Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE) (ITP and SLE)

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ClinicalTrials.gov Identifier: NCT03975361
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study before and after treatment (B-cell reconstitution time).


Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia (ITP) Systemic Lupus Erythematosus (SLE) Other: Bliss-Believe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Bliss-Believe
Patients included in the BLISS-BELIEVE study (NCT03312907).
Other: Bliss-Believe

The samples from the blood samples carried out within the framework of Bliss Believe will be collected for a biological collection. Samples will be obtained the day of inclusion, at the week 36, 40 and week 52.To improve the number of timepoints, patients already included in Bliss Believe can be included in this study if W36, W40, W52 can be obtained. It will be 7ml X 3 (21 ml) of blood every time.

The samples of patients included in RITUX-PLUS STUDY are already collected according to the protocol at baseline, W36, W52.





Primary Outcome Measures :
  1. Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood [ Time Frame: From baseline (week 0) at week 52 ]
    Number of polyreactive and autoreactive cells in immature (central tolerance) and naïve B cells (peripheral tolerance) subsets in the peripheral blood along the RITUX-PLUS and the BLISS BELIEVE studies before and after treatment (reconstitution time).



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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:

  • Patients enrolled in the RITUX-PLUS (NCT03154385)
  • Patients enrolled in the BLISS BELIEVE studies (NCT03312907)

Exclusion Criteria:

  • Patients enrolled in the RITUX-PLUS (NCT03154385)
  • Patients enrolled in the BLISS BELIEVE studies (NCT03312907)

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): NCT03975361


Contacts
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Contact: Mahevas Matthieu 01 49 81 20 76 matthieu.mahevas@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
GlaxoSmithKline
Investigators
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Principal Investigator: Mahevas Matthieu Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03975361     History of Changes
Other Study ID Numbers: APHP180341
2019-A00103-54 ( Other Identifier: IDRCB )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: March 2019

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rituximab

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms