Rituximab Objective Outcome Measures Trial in SLE

Sponsor
University of Leeds
Study ID
NCT03054259
Phase
PHASE2
Status
Unknown

Conditions

  • Systemic Lupus Erythematosus Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 21, 2017
Status verified
Apr 2019
Primary completion
Feb 29, 2020
Completion
Feb 29, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    2 x 1000mg Rituximab and 100mg methylprednisolone
  • Placebo Comparator: Control
    2 x 100mg methylprednisolone plus placebo

Primary Outcome Measure

Feasibility of trial considering adherence to protocol, completion of all assessments and visits [ Time Frame: 26 weeks ]

Central Contacts