Anifrolumab for Systemic Sclerosis (DAISY Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AstraZeneca
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing anifrolumab, an injectable medication, in adults with systemic sclerosis. The goal is to see if it can reduce immune system attacks to lessen symptoms and prevent further damage. Anifrolumab is a human monoclonal antibody that targets the type I interferon receptor and has been tested in multiple studies for systemic lupus erythematosus (SLE) and other autoimmune diseases.
Is the drug Anifrolumab a promising treatment for Systemic Sclerosis?The provided research articles do not contain information about Anifrolumab or its effects on Systemic Sclerosis, so we cannot determine if it is a promising treatment based on this data.124712
What safety data exists for Anifrolumab for Systemic Sclerosis?The provided research does not contain safety data for Anifrolumab or its other names (Anifrolumab-fnia, Saphnelo, MEDI-546, MDX-1333, Anti-IFNaR MAb). The studies focus on the safety and efficacy of sarilumab and tocilizumab for rheumatoid arthritis, which are different treatments.4891012
What data supports the idea that Anifrolumab for Systemic Sclerosis is an effective treatment?The available research does not provide any data on Anifrolumab for Systemic Sclerosis. Instead, the studies focus on other treatments for conditions like rheumatoid arthritis and ankylosing spondylitis. Therefore, there is no information here to support the effectiveness of Anifrolumab for Systemic Sclerosis.3561112
Do I need to stop my current medications to join the trial?The trial allows stable background therapies like hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids, or tacrolimus. You may not need to stop these medications, but check with the trial team for specifics.
Eligibility Criteria
Adults aged 18-70 with systemic sclerosis, meeting specific criteria and having the condition for less than 6 years. They must have certain severity scores, stable therapies are allowed. Excludes those with overlap syndromes, recent malignancies (except some skin cancers), severe organ diseases, or conditions that might affect study results.Inclusion Criteria
My daily activities are somewhat limited due to my health.
I have been diagnosed with systemic sclerosis.
My skin condition affects either small or large areas.
My systemic sclerosis symptoms started within the last 6 years, not counting Raynaud's.
My skin is healthy where injections are given.
I am between 18 and 70 years old.
My skin condition has been severe and active for at least 18 months.
Exclusion Criteria
I have had a stem cell or organ transplant.
I have not had major surgery in the last 8 weeks.
I have a specific autoimmune condition like lupus or rheumatoid arthritis with certain antibodies.
My test shows positive for anticentromere antibodies.
I have had a severe kidney issue due to systemic sclerosis in the last year.
I do not have severe liver, kidney, nerve, hormone, or digestive diseases unrelated to my current condition.
I have had a severe case of shingles.
I do not have severe heart or lung disease.
I have a history of or currently have serious infections.
Treatment Details
The trial is testing Anifrolumab's effectiveness against a placebo in adults with systemic sclerosis. Participants will receive either the real drug or a placebo without knowing which one they're getting. Some may later get Anifrolumab openly.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anifrolumab (subcutaneous weekly injection)Experimental Treatment2 Interventions
Anifrolumab subcutaneous injection once weekly
Group II: matched placebo control (subcutaneous weekly injection)Placebo Group1 Intervention
matched placebo control subcutaneous injection once weekly
Anifrolumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Saphnelo for:
- Moderate to severe systemic lupus erythematosus (SLE)
🇪🇺 Approved in European Union as Saphnelo for:
- Moderate to severe systemic lupus erythematosus (SLE)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Research SiteBrooklyn, NY
Research SiteCalgary, Canada
Research SiteAurora, CO
Research SiteScottsdale, AZ
More Trial Locations
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Who is running the clinical trial?
AstraZenecaLead Sponsor
References
[Adalimumab plus methotrexate for the treatment of rheumatoid arthritis: a multi-center randomized, double-blind, placebo-controlled clinical study.]. [2018]To investigate the efficacy and safety of adalimumab plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA).
[Current "off label use" of methotrexate for chronic inflammatory rheumatic diseases]. [2021]Methotrexate (MTX) is probably the most commonly used off-label drug in rheumatology. It is used as an immunosuppressant for a wide range of chronic inflammatory rheumatic diseases. In most cases there is limited evidence from controlled studies for the efficacy of MTX in this off-label scenario. Only a few controlled clinical trials exist for different types of connective tissue diseases and vasculitis. In most indications, however, MTX could help to avoid using steroids and/or to prevent relapses. Thus, there is a great deal of experience with MTX in an off-label use and MTX is employed in the daily practice by most rheumatologists with success. A commonly used register indexing the off-label use of MTX and also of other disease-modifying antirheumatic drugs (DMARDs) and biologicals would help to improve the acceptance and the safety of MTX as an orphan drug.
The effect of golimumab therapy on disease activity and health-related quality of life in patients with ankylosing spondylitis: 2-year results of the GO-RAISE trial. [2022]To evaluate the effects of golimumab therapy on achieving inactive disease or major improvement, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS), and improvements in health-related quality of life (HRQOL) and productivity through 2 years in patients with AS.
Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. [2022]To evaluate the efficacy and safety of sarilumab in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA).
Real-life effectiveness of Golimumab in biologic-naïve patients with rheumatoid arthritis - data from the Rheumatic Diseases Portuguese Register (Reuma.pt). [2019]To assess the effectiveness of subcutaneous Golimumab 50 mg/monthly combined with methotrexate (SC GLM + MTX) over 52 weeks of treatment, in biologic-naïve RA patients, in a multicentre nationwide cohort from the Rheumatic Diseases Portuguese Register (Reuma.pt).
Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis. [2022]To compare responses in patients with early rheumatoid arthritis (RA) initially treated with the tumour necrosis factor inhibitor (TNFi) adalimumab+methotrexate (MTX) versus MTX monotherapy who may have continued receiving MTX or switched to adalimumab rescue therapy after inadequate response to MTX.
Two years of sarilumab in patients with rheumatoid arthritis and an inadequate response to MTX: safety, efficacy and radiographic outcomes. [2019]To examine 2-year safety, efficacy and radiographic outcomes of sarilumab in adults with RA and inadequate response to MTX (MTX-IR).
Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. [2020]Safety and efficacy of mAbs blocking the IL-6 receptor have been established in RA. This is the first analysis examining safety and tolerability of sarilumab and tocilizumab administered as single or multiple doses in patients with RA within the same study.
Sarilumab monotherapy or in combination with non-methotrexate disease-modifying antirheumatic drugs in active rheumatoid arthritis: A Japan phase 3 trial (HARUKA). [2020]Objectives: To determine long-term safety and efficacy of sarilumab as monotherapy or with non-methotrexate (MTX) conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Japanese patients with active rheumatoid arthritis (RA).Methods: In this double-blind, randomized study (NCT02373202), patients received subcutaneous sarilumab 150 mg q2w (S150) or 200 mg q2w (S200) as monotherapy or with non-MTX csDMARDs for 52 weeks. The primary endpoint was safety.Results: Sixty-one patients received monotherapy (S150, n = 30; S200, n = 31) and 30 received combination therapy (S150 + csDMARDs, n = 15; S200 + csDMARDs, n = 15). Rates of treatment-emergent adverse events (TEAEs) were 83.3%/90.3%/93.3%/86.7% for S150/S200/S150 + csDMARDs/S200 + csDMARDs, respectively. Nasopharyngitis and neutropenia were the most frequently reported TEAEs. One serious infection was reported in each monotherapy group and in the S200 + csDMARDs group. There were no cases of grade 4 neutropenia; no patients with grade 3 neutropenia experienced associated serious infection. Improvements in ACR20/50/70 response rates were generally similar between the two monotherapy groups and between the two combination groups; improvements in physical function (Health Assessment Questionnaire-Disability Index, HAQ-DI) and DAS28-CRP were observed at weeks 24 and 52 (all groups).Conclusion: The safety profile of sarilumab was consistent with known class effects of interleukin-6 signaling blockade therapeutics. Sarilumab as mono- or combination therapy improved clinical signs/symptoms and physical function in Japanese RA patients.
Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. [2021]The objective of this study was to evaluate the long-term safety and efficacy of sarilumab over 5 years in patients with RA refractory to TNF inhibitors (TNFis).
Persistence of bDMARD therapy in Rheumatoid Arthritis after first-line TNF-inhibitor failure: the RECORD study of the Italian Society for Rheumatology. [2022]The optimal choice of a second biological disease-modifying anti-rheumatic drug (bDMARD) after failure with first line tumour necrosis factor inhibitor (TNFi) represents a critical therapeutic challenge. This study aims to evaluate the persistence with treatment using second line bDMARDs with different mechanisms of action in rheumatoid arthritis (RA) patients with inadequate response to first line TNFi.
Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: a network meta-analysis of randomized controlled trials. [2023]This study compared the relative efficacy and safety of olokizumab, tocilizumab, and sarilumab in rheumatoid arthritis (RA) patients who were intolerant or responding inadequately to methotrexate (MTX).