Comparison of two treatments rituximab in patients with autoimmune disease resistant to conventional treatments

Phase 1

• Conditions: ong-term relapse after treatment of lupus nephritis (LN) resistant to conventional treatment; MedDRA version: 14.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-005856-32-ES
• Lead Sponsor: Fundación Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-27
• Study Completion: 2017-09-27
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

- Both men and women between 18 and 70 years.

-Patient with active lupus nephritis, previously treated with the following immunosuppressive unless contraindication: cyclophosphamide, azathioprine and mycophenolate (sodium or mophetil), who have not received rituximab in the two previous years, in whom regime was ineffective at least 3 months after treatment, or who experienced relapse during this time.

- Informed consent form signed.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

-Active/sepsis serious infections

-Known neoplasia

- Heart failure with III/IV functional class

-Pregnancy

-Nursing

-Known anaphylaxis to the product

-Cardiovascular disease or uncontrolled hypertension

-Chronic hepatitis B

-Serious Citopenia (granulocytes < 500/mm3, further < 10000/mm3)

-Immunodeficiency (CVI, IgA deficiency)

-Infection with HIV

Study & Design

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