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A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus

RecruitingPhase 3Ages 18 Years - 70 YearsAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines). Further, it aims to describe outcomes alongside a systematic approach to glucocorticoid (GC) tapering, in terms of effectively minimising GC use, as well as discontinuing GC use, thereby reducing GC exposure.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Informed Consent 1. Capable of giving signed informed consent. Age 2. Participant must be 18 to 70 years of age inclusive, at the time of signing the ICF. Disease Characteristics 3. Participants who have a diagnosis of SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria (Appendix D), confirmed by a rheumatologist 4. ANA-positive as determined by a documented historical test result confirmed at Screening, for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80), or at least one of the following: 1. Anti-dsDNA (b) Anti-Smith (anti-Sm) Note: Retesting of autoantibodies is allowed once during Screening. 5. To be eligible a participant must have SLEDAI-2K ≥6 or clinical SLEDAI-2K ≥ 4 points: 1. In order to qualify for SLEDAI-2K score for arthritis at Screening, participant must have at least 3 joints with tenderness AND swelling (same joints) due to SLE. 2. In order to qualify for SLEDAI-2K score for rash at Screening, participant must have rash with significant erythema (not only faint pink erythema) 3. Clinical SLEDAI-2K points at Screening cannot only be due to one of the following (but a combination is permitted): fever, diffuse alopecia or mucosal ulcers. NB. Presence of fever or mucosal ulcers must be documented by the investigator at the visit. Patchy alopecia which includes a change in normal scalp colour, is permitted as a sole contributor to Clinical SLEDAI-2K score. 6. PGA score ≥ 1.0 on a 0 to 3 visual analogue scale (VAS) at Screening. 7. Must be receiving at least one of the following standard therapy regimens at Screening: a) Oral prednisone (or equivalent) monotherapy: i. Must be stable (including prednisone or equivalent = 0 mg/day) for \> 2 weeks before 1st anifrolumab infusion. ii. Maximum daily dose: ≤ 40 mg/day. b) Antimalarials and/or immunosuppressant(s) with or without GC: i. Permitted medications include: antimalarials, azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, mizoribine, tacrolimus, and cyclosporine (Note: The combination of azathioprine and methotrexate is not allowed due to known safety issues. The combinations of tacrolimus/cyclosporine with other immunosuppressants above should be avoided. Combination with antimalarials is allowed.). ii. Start date: ≥ 12 weeks prior to signing the ICF. iii. Must be stable ≥ 8 weeks prior to signing the ICF. iv. The daily dose should follow the medical practice and not exceed the maximum allowed daily dose: v. Azathioprine: ≤ 200 mg/day. vi. Mycophenolate mofetil ≤ 2 g/day or mycophenolic acid ≤ 1.44 g/day. vii. Oral, subcutaneous (SC), or intramuscular methotrexate ≤ 25 mg/week. viii. Mizoribine ≤ 150 mg/day. ix. Tacrolimus ≤ 0.2 mg/kg/day or cyclosporine ≤ 5 mg/kg/day, monitoring of serum concentration may be performed at the discretion of Investigator where practice guidelines mandate or in case of safety concerns. c) Oral prednisone (or equivalent) plus immunosuppressant(s): i. Start dates for GC and immunosuppressants must be met. ii. Stability requirements for each medication must be met. iii. No minimum daily dose for GC when in combination with immunosuppressants. iv. Maximum daily dosages for each medication in (a) and (b) must not be exceeded. 8. Chest x-ray (obtained during Screening or within 12 weeks prior to signing of the ICF) or a computed tomography (CT) scan of the chest (within 12 weeks of signing the informed consent) which meets all the following: 1. No evidence of current active infection (e.g., pneumonia, tuberculosis \[TB\]) or previous TB; and 2. No evidence of malignancy; and 3. No clinically significant abnormalities (unless due to SLE). 9. TB Testing for Inclusion in the study: the participant must undergo an IGRA (e.g., QuantiFERON-Tuberculosis Gold \[QFT G test\]) test for TB obtained from the study central laboratory at Screening with any of the following results: Negative test result Positive test result: referral to a TB specialist for evaluation and for which active TB has been ruled out (as described in the protocol definition), and initiation of treatment for latent TB prior to the first administration of study intervention in accordance with local SoC. Indeterminate test result confirmed by repeat test using the same assay o The participant must be referred to a TB specialist for evaluation (with assessment and treatment recommendation comprehensively documented in source) and initiation of appropriate latent TB treatment, if warranted, prior to the first administration of study intervention. If no latent TB treatment is warranted, the participant may enter the study without latent TB treatment but must be retested at least every 12 months. If the retest result is indeterminate or negative, the participant may continue in the study with routine testing. o If, upon retest, the result is indeterminate, the participant may continue in the study without treatment. The participant will continue routine TB testing as outlined in the SoA (Section 1.3). Weight 10. Body weight ≥ 40 kg. Sex 11. Female participants: a) Negative serum β-hCG test at Screening (females of childbearing potential only). b) Women of childbearing potential must have a negative urine pregnancy test at Week0(Day 1), prior to administration of study intervention. c) Women of non-childbearing potential must be postmenopausal or have been surgically sterilized (for example: bilateral oophorectomy, bilateral salpingectomy, or complete hysterectomy), which should be documented in the participant's medical records. The following age-specific requirements may apply for a postmenopausal state: i. Women who were taking HRT (Hormone Replacement Therapy): <!-- --> 1. Women \< 50 years old will be considered postmenopausal if they have been amenorrhoeic for ≥ 12 months following cessation of HRT and the FSH
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What it tests

  • Anifrolumab
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Where

74 sites
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Bengbu, China
Research Site
Changchun, China
Research Site
Changchun, China
Research Site
Changchun, China

…and 66 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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