Rituximab Objective Outcome Measures Trial in SLE (ROOTS)
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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West Yorkshire
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Leeds, West Yorkshire, Reino Unido, LS7 4SA
- Recrutamento
- Chapel Allerton Hospital- Leeds Institute for Rheumatic and Musculoskeletal Medicine
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Contato:
- Edward Vital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults aged at least 18 years old
- Active musculoskeletal SLE defined by inflammatory musculoskeletal pain with either clinical synovitis, ultrasound tenosynovitis or positive power Doppler in at least 1 joint
- No contraindication to the use of IV methylprednisolone, biosimilar rituximab, or any other required medications such as antipyretics and antihistamines
- Willing to use appropriate contraception if at risk of pregnancy
- Disease activity that is refractory to hydroxychoroquine, or patients unable to take hydroxychoroquine due to contra-indication or prior toxicity
Exclusion Criteria:
• Severe "critical" SLE flare defined as: (i) BILAG 2004 A flare in CNS system; (ii) BILAG 2004 A flare in the renal system; or (iii) any other SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion
- Pregnancy
- Breast Feeding
- Receipt of daily oral glucocorticoids greater than 10mg prednisolone or equivalent at screening or within the previous 5 days, or change in glucocorticoid dose in the previous 5 days.
- Receipt of intramuscular or intravenous glucocorticoids within the past 4 weeks
- Receipt of intravenous immunoglobulin, plasma exchange or cyclophosphamide within the last 3 months
- Rituximab within the past 18 months or other biologic therapies within the past 6 months
- Active infections, including but not limited to the human immunodeficiency virus, hepatitis B (including prior infection as judged by positive Hepatitis B core antibody) or hepatitis C
- Serum IgG below the lower limit of the local laboratory range
- Receipt of a live attenuated vaccine within 3 months prior to study enrolment
- History of cancer in the past 5 years except for squamous or basal cell carcinoma that has been completely excised or treated cervical carcinoma in situ
- In female participants, known history of cervical dysplasia CIN Grade III cervical high-risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. The patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated >1 year ago)
- Planned surgery within the study period that is expected to require overnight hospital admission
- Any other concomitant medical condition that, in the investigator's opinion, or after discussion with the CI, places the participant at risk by participating in this study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
2 x 1000mg Rituximab and 100mg methylprednisolone
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1000mg rituximab infusions on days 1 and 15 (monoclonal antibody)
100mg infusion on days 1 and 15
250ml infusion on days 1 and 15
|
|
Comparador de Placebo: Control
2 x 100mg methylprednisolone plus placebo
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100mg infusion on days 1 and 15
250ml infusion on days 1 and 15
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of trial considering adherence to protocol, completion of all assessments and visits
Prazo: 26 weeks
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Overall feasibility of the trial will be judged based on the feasibility variables.
It is acknowledged that this trial incorporates multiple inter-related aspects of design, with many possible modifications in trials derived from it.
Hence these numbers will be used as a guide only and specific target values have not been defined.
|
26 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of patients achieving BILAG-based Composite Lupus Assessment (BICLA)
Prazo: 16 weeks
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An assesment of clinical efficacy of treatment
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16 weeks
|
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Proportion of patients achieving SLEDAI responder Index (SRI)
Prazo: 16 weeks
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An assesment of clinical efficacy of treatment
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16 weeks
|
|
Number of serious adverse events
Prazo: 26 weeks
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Safety assessment
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26 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Doenças autoimunes
- Doenças do Tecido Conjuntivo
- Lúpus Eritematoso Sistêmico
- Efeitos Fisiológicos das Drogas
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Antiinflamatórios
- Agentes Antirreumáticos
- Agentes Antineoplásicos
- Fatores imunológicos
- Antieméticos
- Agentes gastrointestinais
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Agentes Neuroprotetores
- Agentes de proteção
- Agentes Antineoplásicos Imunológicos
- Prednisolona
- Acetato de Metilprednisolona
- Metilprednisolona
- Hemisuccinato de Metilprednisolona
- Acetato de prednisolona
- Hemisuccinato de prednisolona
- Fosfato de prednisolona
- Rituximabe
Outros números de identificação do estudo
- RR15/197
- 2015-002688-40 (Número EudraCT)
- 16/YH/0032 (Outro identificador: Research Ethics Committee Reference Number)
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