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Rituximab Objective Outcome Measures Trial in SLE

NCT03054259 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03054259 on ClinicalTrials.gov