Study on the Effectiveness and Safety of Obinutuzumab for Patients with Systemic Lupus Erythematosus

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Obinutuzumab in patients with a condition known as Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease, which means the body’s immune system mistakenly attacks its own tissues, causing inflammation and damage to various parts of the body. The study aims to evaluate how effective and safe Obinutuzumab is for people with SLE. Participants in the study will receive either Obinutuzumab or a placebo, which is a substance with no active medication.

The study will be conducted over a period of time, during which participants will receive the treatment through an intravenous infusion, meaning the medication is given directly into a vein. The study will monitor the participants’ response to the treatment, looking at various health indicators to determine if the medication helps reduce the symptoms of SLE. The goal is to see if Obinutuzumab can help more people achieve a better state of health compared to those who do not receive the active medication.

Throughout the study, participants will be regularly assessed to track their progress and any changes in their condition. The study will also keep an eye on any side effects or adverse events that may occur. By the end of the study, researchers hope to gather enough information to understand the potential benefits and risks of using Obinutuzumab for treating Systemic Lupus Erythematosus.

1 joining the study

Upon joining the study, the patient will be assessed to confirm a diagnosis of systemic lupus erythematosus (SLE) based on specific criteria.

The patient must have high disease activity and be on stable doses of standard therapies for SLE.

2 treatment administration

The patient will receive either obinutuzumab or a placebo. Obinutuzumab is administered as a solution for infusion through an intravenous infusion.

The specific dosage and frequency of administration will be determined by the study protocol.

3 monitoring and assessments

Throughout the study, the patient’s response to treatment will be monitored using the Systemic Lupus Erythematosus Responder Index (SRI) at various time points, including Week 24 and Week 52.

Additional assessments will include monitoring of disease activity, corticosteroid use, and any adverse events.

4 completion of study

The study is expected to continue until November 2027.

Upon completion, the patient’s overall response to the treatment will be evaluated, including any changes in disease activity and quality of life measures.

Who Can Join the Study?

  • Must have a diagnosis of Systemic Lupus Erythematosus (SLE) according to specific criteria set by medical organizations, confirmed at least 12 weeks before the screening.
  • Must have certain antibodies in the blood, such as anti-nuclear antibody (ANA) at a level of 1:80 or higher, or other specific antibodies like anti-dsDNA or anti-Sm above normal levels, as checked by a central lab during screening.
  • Must have low levels of certain proteins in the blood called complements (C3, C4, or CH50), which help the immune system, as determined by a central lab during screening. Low C3 is necessary if there is a known genetic deficiency of C4.
  • Must have high disease activity at screening, which means having severe symptoms in at least one organ system or moderate symptoms in two or more organ systems, as measured by specific medical assessments.
  • Must have high disease activity on the first day of the study, based on specific scores from medical assessments.
  • Must currently be taking at least one type of standard treatment for SLE at stable doses, such as oral corticosteroids, antimalarials, or conventional immunosuppressants.
  • Both females and males are eligible to participate.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection or illness that could affect the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who have received certain treatments recently that could interfere with the study.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Universita’ Degli Studi Di Ferrara Ferrara Italy
Hospital Universitario Basurto Bilbao Spain
Rheuma Medicus Sp. z o.o. Warsaw Poland
Azienda Ospedaliera di Padova Padua Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Medyczne Centrum Hetmanska Poznan Poland
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Universita’ Di Pisa Pisa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nice Nice France
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu Poznan Poland
Msudgizho Iobkyluhso Ccslqaxg Ssabpckh Srt z osqd Warsaw Poland
Camopedx Hxmkjrhinfob Ugtebssukmtrr Dl Vjfl Vigo Spain
Hbadpmyh Vksk dwhpplru Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
10.03.2022
France France
Not recruiting
10.03.2022
Italy Italy
Not recruiting
10.03.2022
Poland Poland
Not recruiting
10.03.2022
Spain Spain
Not recruiting
10.03.2022

Trial locations

Investigated drugs:

Obinutuzumab is a medication being studied for its effectiveness in treating patients with systemic lupus erythematosus, a chronic autoimmune disease. It works by targeting specific cells in the immune system to reduce inflammation and other symptoms associated with lupus. The trial aims to determine how well this medication helps patients achieve a better response to their condition compared to those who do not receive it.

Systemic Lupus Erythematosus (SLE) – Systemic Lupus Erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease is characterized by periods of illness, called flares, and periods of wellness, or remission. Symptoms can vary widely among individuals and may include fatigue, joint pain, skin rashes, and fever. Over time, SLE can lead to inflammation and damage in the affected organs. The progression of the disease is unpredictable, with symptoms ranging from mild to severe.

Trial ID:
2023-504774-38-00
Protocol code:
CA42750
Trial Phase:
Therapeutic confirmatory (Phase III)

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