Very low doses of Rituximab for autoimmune diseases, for which rituximab is not approved for - a Pilot Trial

Phase 1

• Conditions: Autoimmune-haemolytic AnemiaAntiphospholipid SyndromeImmune-mediated Thrombocytopenia; MedDRA version: 20.0Level: LLTClassification code 10003825Term: Autoimmune hemolytic anemiaSystem Organ Class: 100000154058; MedDRA version: 20.0Level: PTClassification code 10002817Term: Antiphospholipid syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: LLTClassification code 10023095Term: ITPSystem Organ Class: 100000157088; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-002478-11-AT
• Lead Sponsor: Medical University of Vienna, Department of Internal medicine I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

•Signed informed consent obtained before any trial related activities
•Ability to understand the nature and the purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the trial
•Men or women aged =18 years of age with a diagnosis of autoimmune-mediated haemolytic anemia, antiphospholipid syndrome or immune-mediated thrombocytopenia
•In female subjects either childbearing potential terminated by surgery or one year post- menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
•Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
•Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

•Previous treatment with rituximab, obinutuzumab, ofatumumab or ocrelizumab within 12 months
•Clinically relevant infection (<1 week)
• Intravenous immunoglobulins, unless cyclic thrombocytopenia occures
•Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that may interfere with the aim of the study
•Ascertained or presumed hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the participants
•Use of medication during 2 weeks before the start of the study, which the investigator considers may affect the validity of the study
•Drug abuse, alcohol (>1 drinks/day, defined according to USDA Dietary Guidelines)
•Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified