NCT03054259

Rituximab Objective Outcome Measures Trial in SLE

A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a feasibility study to test a new trial design for an important drug in Systemic Lupus Erythematosus (SLE or "lupus"). SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of the body may be affected, but most commonly lupus causes a rash and arthritis, this affects patients' quality of life. Lupus is usually treated with steroids or drugs that suppress the immune system. Although these help, many patients don't respond well enough and there is also concern for long term side effects. There is a new type of treatment called biologics. These target individual cells or molecules rather than the whole immune system and may be more effective with fewer side-effects. B cells are a part of the immune system that are known to play a role in lupus. There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials. However, in lupus clinical trials it did not seem to show any benefit. But many doctors and patients found that rituximab is effective, but the trials couldn't show this because of the way the drug's effects were measured. Therefore it is important that we test whether it truly is effective for lupus. In this 6 month clinical study the investigators will look at lupus patients who have skin disease and arthritis as these are very common and randomise them to receive either rituximab or a placebo. Patients will have a careful clinical examination and undergo different methods to measure the effectiveness of the treatment. There are new versions to rituximab called "biosimilars". In this study biosimilar GP2013 will be used. If this trial is successful a larger definitive study will be designed based on its results.

Conditions

• Systemic Lupus Erythematosus Arthritis

Interventions

Type	Name	Description
DRUG	Rituximab	1000mg rituximab infusions on days 1 and 15 (monoclonal antibody)
DRUG	Methylprednisolone	100mg infusion on days 1 and 15
DRUG	Normal Saline	250ml infusion on days 1 and 15

Timeline

• Start date: 2017-09-21
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2017-02-15
• Last updated: 2019-05-01

Locations

1 site across 1 country: United Kingdom