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Rituximab Objective Outcome Measures Trial in SLE (ROOTS)

30 april 2019 uppdaterad av: University of Leeds

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

30

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Storbritannien
    • West Yorkshire
      • Leeds, West Yorkshire, Storbritannien, LS7 4SA
        • Rekrytering
        • Chapel Allerton Hospital- Leeds Institute for Rheumatic and Musculoskeletal Medicine
        • Kontakt:
          • Edward Vital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention
2 x 1000mg Rituximab and 100mg methylprednisolone
Läkemedel: Rituximab
1000mg rituximab infusions on days 1 and 15 (monoclonal antibody)
Läkemedel: Methylprednisolone
100mg infusion on days 1 and 15
Läkemedel: Normal Saline
250ml infusion on days 1 and 15
Placebo-jämförare: Control
2 x 100mg methylprednisolone plus placebo
Läkemedel: Methylprednisolone
100mg infusion on days 1 and 15
Läkemedel: Normal Saline
250ml infusion on days 1 and 15

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of trial considering adherence to protocol, completion of all assessments and visits
Tidsram: 26 weeks
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients achieving BILAG-based Composite Lupus Assessment (BICLA)
Tidsram: 16 weeks
An assesment of clinical efficacy of treatment
16 weeks
Proportion of patients achieving SLEDAI responder Index (SRI)
Tidsram: 16 weeks
An assesment of clinical efficacy of treatment
16 weeks
Number of serious adverse events
Tidsram: 26 weeks
Safety assessment
26 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Leeds

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 september 2017

Primärt slutförande (Förväntat)

1 februari 2020

Avslutad studie (Förväntat)

1 februari 2020

Studieregistreringsdatum

Först inskickad

17 januari 2017

Först inskickad som uppfyllde QC-kriterierna

10 februari 2017

Första postat (Faktisk)

15 februari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 april 2019

Senast verifierad

1 april 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RR15/197
  • 2015-002688-40 (EudraCT-nummer)
  • 16/YH/0032 (Annan identifierare: Research Ethics Committee Reference Number)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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