ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07330245 (DAHLIA) के लिए लुपस एरिथेमेटोसस, प्रणालीगत वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
एस्ट्राजेनेकाAchievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. (DAHLIA) 218 अवलोकनात्मक
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07330245 (DAHLIA) एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो लुपस एरिथेमेटोसस, प्रणालीगत से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 31 दिसंबर 2025 को हुई थी, और इसमें कुल 218 प्रतिभागियों के नामांकन की योजना है। एस्ट्राजेनेका इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 सितंबर 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 4 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5
विस्तृत विवरण
DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study p...और दिखाएँ
आधिकारिक शीर्षक
DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy
स्वास्थ्य स्थितियां
लुपस एरिथेमेटोसस, प्रणालीगतअन्य अध्ययन आईडी
- DAHLIA
- D3461R00093
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-12-31
अंतिम अद्यतन प्रकाशित
2026-03-04
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-09-30
नामांकन (अनुमानित)
218
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
भर्ती जारी
प्रमुख शब्द
Lupus Erythematosus, Systemic.
Anifrolumab.
Anifrolumab.
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
निर्दिष्ट नहीं | Anifrolumab anifrolumab - fully human monoclonal antibody target type I INF |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Number and percentage of patients achieving LLDAS5 | proportion of patients with LLDAS5 at 52 weeks, defined as:
LLDAS5 is defined as follows:
* Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity;
* No new lupus disease activity compared with previous assessment as defined per protocol;
* Physician's Global Assessment (PGA) ≤1;
* Current prednisone (-equivalent) dose ≤ 5mg/day;
* Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any. | 52 weeks |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Number and percentage of patients reaching LLDAS5 at each time point | Proportion of patients with LLDAS5, according the following definition:
LLDAS5 is defined as follows:
* Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity;
* No new lupus disease activity compared with previous assessment as defined per protocol;
* Physician's Global Assessment (PGA) ≤1;
* Current prednisone (-equivalent) dose ≤ 5mg/day;
* Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any. | week 24, 76 and 104 |
Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction | Number and percentage of patients achieving a GCS dose reduction (to ≤ 5 mg/day; to 0 mg/day) at different timepoints (T1, T2, T3, T4, T5, T6) compared to T0 | week 4, 12, 24, 52, 76, 104 vs baseline |
Median (range) cumulative dose of GCS | Median cumulative dose of GCS calculated at each 6 month period following T0 | from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104 |
Mean(SD) change in tender and swollen joint count | Mean change in tender and swollen joint count using Disease Activity Score 28 (DAS28) map at different timepoints compared to baseline (w0). DAS28 ranges from 0 (no-activity) to 10 (high disease activity) | week 4, 12, 24, 52, 76 and 104 vs week 0 |
mean (SD) change in Power Doppler (PD) Signal Total score | Mean change in Power Doppler (PD) Signal at each time point vs baseline. PD Signal ranges from 0 (low) to 84 (high) | week 4, 12, 24, 52, 76 and 104 vs week 0 |
mean (SD) change in Synovial Hypertrophy (SH) Total score | Mean change in synovial hypertrophy at each time point vs baseline. Synovial hypertrophy ranges from 0 (low) to 84 (high). | week 4, 12, 24, 52, 76 and 104 vs week 0 |
Annualize flaire rate | Annualized flare rate in the first and second years | week 52 and week 104 |
Number and percentage of patients meeting the DORIS clinical remission | Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:
* Clinical SLEDAI-2K = 0;
* PGA \< 0.5;
* Prednisolone ≤ 5 mg/day | week 12, 24, 52, 76 and 104 |
Number and percentage of patients with sustained DORIS remission | Number and percentage of patients with sustained DORIS remission, defined as remaining in remission at or greater than 12 weeks after having met the DORIS definition | week 104 |
Mean (SD) HDRS (Hamilton Depression Rating Scale) total score | Change in HDRS total score at different timepoints compared to T0. HDRS ranges from 0 (no depression) to 54 (severe) | week 12, 24, 52 and 104 vs week 0 |
Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score | Change in PROMIS Depression Short Form 8b total score at different timepoints compared to week 0 (baseline). PROMIS raw scores ranges from 8 (no depression) to 40 (severe) | week 12, 24, 52 and 104 vs week 0 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए पात्र लिंग
सभी
- Provided informed consent to participate in the study;
- Aged 18 years or older;
- Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;
- Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;
- Patients who are at LLDAS5 at the time of study entry;
- Previous exposure to anifrolumab;
- Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy \[mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids\], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus
- Currently participating in any interventional clinical trial with an investigational product;
- Inability to understand and sign the informed consent and to fill in patient questionnaires
एस्ट्राजेनेकाअध्ययन केंद्रीय संपर्क
संपर्क: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
19 1 देशों में अध्ययन स्थान
CA
Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato, Monserrato, CA, 09032, Italy
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Ferrara
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna, Cona, Ferrara, 44124, Italy
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Milano
IRCCS Humanitas Research Hospital, Rozzano, Milano, 20089, Italy
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AOU Ospedali Riuniti di Ancona - Presidio Torrette, Ancona, 60126, Italy
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Azienda Ospedaliero-Universitaria Policlinico di Bari, Bari, 70124, Italy
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ASST Spedali Civili di Brescia, Brescia, 25123, Italy
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Azienda Ospedaliero-Universitaria Careggi, Florence, 50134, Italy
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, 20122, Italy
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Policlinico di Modena - AOU di Modena, Modena, 41124, Italy
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Azienda Ospedaliera di Padova, Padua, 35128, Italy
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Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy
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Fondazione IRCCS Policlinico San Matteo, Pavia, 27100, Italy
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Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara, Pisa, 56126, Italy
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Policlinico Tor Vergata, Roma, 00133, Italy
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Policlinico Umberto I - Sapienza Università di Roma, Roma, 00161, Italy
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Azienda Ospedaliera Ordine Mauriziano Umberto I, Torino, 10128, Italy
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Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara, Trieste, 34128, Italy
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ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine, Udine, 33100, Italy
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AOUI Verona - Ospedale Borgo Roma, Verona, 37134, Italy
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