Rituximab for Gout

Overseen By John FitzGerald, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Los Angeles

Must be taking: Rituximab, Methotrexate

Must not be taking: Steroids, Investigational drugs

Disqualifiers: Renal impairment, Heart failure, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 35

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Rituximab, a medication, to determine if it can help individuals with difficult-to-treat gout manage their symptoms more effectively. The goal is to see if Rituximab can restore the effectiveness of Pegloticase for those who no longer respond to it. Suitable candidates for this trial include individuals with gout not well-controlled by other medications and who have experienced at least two flare-ups in the past year. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking medical research.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking any oral urate lowering therapy at least 7 days before the first Pegloticase infusion and remain off it during the Pegloticase infusions.

Is there any evidence suggesting that Rituximab is likely to be safe for humans?

Research has shown that Rituximab is generally safe. One study found that switching between different versions of Rituximab did not increase side effects, indicating the treatment is well-tolerated. Another study reported an infection rate of 18.1 per 100 patient-years, suggesting that while some may experience infections during treatment, it is not very common.

Rituximab is already approved for treating other conditions, indicating its safety for human use. Clinical trials have not reported major issues from excessive doses. Overall, Rituximab has a good safety record, but regular check-ups during treatment are recommended. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for gout, which often include medications like allopurinol or febuxostat that lower uric acid levels, rituximab offers a fresh approach by targeting the immune system. Rituximab is a monoclonal antibody that specifically targets and depletes B cells, which are part of the immune response that can contribute to inflammation in gout. This unique mechanism of action is what sets rituximab apart and has researchers excited about its potential to reduce gout flare-ups and inflammation more effectively. Additionally, its administration via intravenous infusion provides a different delivery method that might offer benefits for certain patients, especially those who haven't responded well to standard oral therapies.

What evidence suggests that Rituximab might be an effective treatment for gout?

Research suggests that rituximab might help people with gout by influencing the immune system. Some studies have used it for conditions involving the immune system, such as gout. Rituximab targets specific immune cells, known as B cells, which may cause inflammation and joint pain in gout. Although direct evidence on rituximab for gout is limited, its effect on the immune system suggests it could enhance the response to other gout treatments. This trial will evaluate rituximab as an option for those who haven't found success with other gout medications. ^{1 6 7 8 9}

Who Is on the Research Team?

John FitzGerald, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for people with severe gout who can't take or haven't had success with standard oral treatments and have stopped responding to Pegloticase. They'll be given Rituximab before restarting Methotrexate-Pegloticase therapy.

Inclusion Criteria

Meets the American College of Rheumatology Classification Criteria for Gout

I agree to stop my gout medication 7 days before starting Pegloticase treatment.

I stopped taking Pegloticase because it didn't work or caused a bad reaction.

Exclusion Criteria

Pregnant, planning to become pregnant, breastfeeding, or not on an effective form of birth control

Anaphylaxis or other prior severe infusion reaction to Pegloticase

Abnormal blood cell counts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Rituximab Pre-Treatment

Rituximab 1000 mg administered at week -6 and week -4 via intravenous infusion over 5 hours

6 weeks

2 visits (in-person)

Methotrexate Treatment

Methotrexate 15 mg orally once weekly, started 4 weeks prior to Pegloticase initiation

6 weeks

4 visits (virtual)

Methotrexate-Pegloticase Study Treatment

Methotrexate administered weekly and Pegloticase coadministered every two weeks for up to 12 months

12 months

26 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

2 visits (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Rituximab

Trial Overview The study is testing if giving Rituximab, an immune system-modifying drug, before resuming a combination of Methotrexate and Pegloticase helps patients with tough-to-treat gout respond better to treatment.

How Is the Trial Designed?

Group I: Rituximab Experimental Treatment 1 Intervention

Rituximab 1000 mg will be administered at week -6 and week -4 via intravenous infusion over the duration of 5 hours prior to the Pegloticase (Standard-of-Care) treatment.

Rituximab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Rituxan for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Approved in European Union as MabThera for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Approved in Canada as Rituxan for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Rituximab is a genetically engineered monoclonal antibody that effectively targets CD20-positive B-cell malignancies, making it a key treatment for conditions like non-Hodgkin lymphoma and chronic lymphocytic leukemia.

While rituximab is effective for various B-cell related diseases, it carries significant risks, including severe infusion reactions and other serious side effects, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of rituximab in cutaneous medicine. Scheinfeld, N.[2020]

Tocilizumab is an effective treatment option for rheumatoid arthritis in patients who have not responded to other therapies, but it is not more effective than rituximab in cases of multiple treatment failures, based on clinical evaluations of four placebo-controlled trials.

While tocilizumab offers convenience with intravenous administration every four weeks, it carries significant risks of serious infections and other adverse effects, and its long-term safety profile, particularly regarding cancer risk, remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tocilizumab: new drug. Rheumatoid arthritis: another 'mab', no therapeutic advantage. [2016]

Rituximab (RTX) showed a high overall response rate of 61.3% in patients with refractory granulomatosis with polyangiitis (GPA), with complete remission achieved in 9.3% of cases, indicating its efficacy in treating this condition.

Granulomatous manifestations, particularly orbital masses, were more resistant to RTX treatment compared to vasculitic manifestations, with a significant difference in response rates (89.2% for renal disease vs. 44.4% for orbital masses), highlighting the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab for refractory granulomatosis with polyangiitis (Wegener's granulomatosis): comparison of efficacy in granulomatous versus vasculitic manifestations. Holle, JU., Dubrau, C., Herlyn, K., et al.[2022]

Rituximab is primarily indicated for refractory immune thrombocytopenic purpura and is considered the best treatment for cold agglutinin disease, but its long-term benefit-to-risk ratio remains uncertain, especially in relation to splenectomy.

While rituximab shows promise in treating various autoimmune diseases, including Wegener granulomatosis and HCV-associated cryoglobulinemia, there are significant risks of adverse events, particularly infections and severe reactions in certain patient populations, highlighting the need for further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab off label use for difficult-to-treat auto-immune diseases: reappraisal of benefits and risks. Sailler, L.[2022]

Rituximab has been shown to be very safe over more than 10 years of use, but it can significantly increase the risk of infections, especially in patients with low-grade lymphoma or severe immunodeficiency, such as those with HIV or on immunosuppressive therapies.

The most critical infection associated with rituximab is hepatitis B reactivation, which can lead to severe liver failure; therefore, screening for hepatitis B and considering preemptive antiviral treatment is essential for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab-associated infections. Gea-Banacloche, JC.[2020]

Citations

1. the-rheumatologist.org the-rheumatologist.org/article/options-for-refractory-gout-ild-more/?singlepage=1

Options for Refractory Gout, ILD & More Overall, by week 48 we saw about a 5% improvement in FVC in the cyclophosphamide group and approximately a 4% improvement compared to baseline in the rituximab ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK564374/

Rituximab - StatPearls - NCBI Bookshelf In randomized controlled trials, allergic or anaphylactic reactions were seen in 80% to 90% of patients receiving rituximab.

3. nhpri.org nhpri.org/blobnhpri08e0944faa/wp-content/uploads/2025/10/CMP_Rituxan_NonOnc_20250528.pdf

Rituxan (rituximab) and Biosimilar (Truxima, Riabni, ... • For new start to therapy and requesting Rituxan or Riabni, patient must have failure or intolerable side effects to Ruxience or Truxima OR patients that are ...

4. aetna.com aetna.com/cpb/medical/data/300_399/0314.html

Rituximab - Medical Clinical Policy Bulletins The efficacy data used to determine equivalent efficacy of a biosimilar to a reference biologic is contained in publicly available FDA reviews and in the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3654180/

Rituximab for the First-Line Maintenance Treatment of ... The clinical data for the effectiveness of rituximab as a maintenance treatment appeared to be promising. However, trials with immature outcome data pose ...

6. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/index/exchange/rituxan-rituximab-iex-08012024.pdf

Rituximab (Riabni®, Rituxan®, Ruxience®, & Truxima®) results in large, controlled clinical trials. *Rituxan Hycela is ... safety of rituximab treatment. Of 30 patients, 26 (87%) exhibited ...

7. pharmacytimes.com pharmacytimes.com/view/clinical-safety-data-show-switching-between-rituximab-biosimilars-does-not-increase-adverse-events

Clinical Safety Data Show Switching Between Rituximab ... New clinical safety data show that switching between rituximab biosimilars does not increase the risk of adverse events, according to a study published in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3218885/

Safety and clinical outcomes of rituximab therapy in patients ... During treatment with rituximab, there was an overall rate of infection of 18.1 per 100 patient-years. The patient groups with the highest rate of infection ...

9. the-rheumatologist.org the-rheumatologist.org/article/fda-approves-rituximab-biosimilar-plus-new-safety-data-for-filgotinib-in-ra-patients/

FDA Approves Rituximab Biosimilar; Plus New Safety Data ... FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients ... In late November, the U.S. Food and Drug Administration ...