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क्लिनिकल ट्रायल NCT07286214 के लिए पॉलीमायल्जिया रूमेटिका वर्तमान में अभी भर्ती शुरू नहीं 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
सनोफीSarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica चरण IV 300 रैंडमाइज़्ड डबल-ब्लाइंड प्लेसबो-नियंत्रित
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 NCT07286214 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन पॉलीमायल्जिया रूमेटिका से जुड़ा हुआ है और यह एक चरण IV हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 300 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 15 अप्रैल 2026 से शुरू होगा। सनोफी इस परीक्षण का नेतृत्व कर रहे हैं और इसके 16 जुलाई 2029 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 10 फ़रवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilum...और दिखाएँ
आधिकारिक शीर्षक
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica
स्वास्थ्य स्थितियां
पॉलीमायल्जिया रूमेटिकाअन्य अध्ययन आईडी
- EFC18055
- 2024-511296-15-00 (ईयू परीक्षण (सीटीआईएस) संख्या)
- U1111-1310-5173 (रजिस्ट्री पहचानकर्ता) (ICTRP)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-04-15
अंतिम अद्यतन प्रकाशित
2026-02-10
अध्ययन की समाप्ति तिथि (अनुमानित)
2029-07-16
नामांकन (अनुमानित)
300
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण IV
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्लेसबो तुलना समूहPlacebo Participants will receive placebo with prednisone taper | प्लेसबो Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous |
प्रयोगात्मकSarilumab 150 mg Participants will receive 150 mg sarilumab q2w with prednisone taper | Sarilumab Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous |
प्रयोगात्मकSarilumab 200 mg Participants will receive 200 mg sarilumab q2w with prednisone taper | Sarilumab Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper | No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy). | at Week 52 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper | No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy). | at Week 52 |
Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper | No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy). | at Week 52 |
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody | AEs that develop or worsen or became serious during the treatment period (from first dose to 60 days after last dose). | over the entire study period (up to Week 58) |
Corticosteroid-free remission at Week 52 | Remission, without receipt of systemic corticosteroids (CS) or rescue treatment within 7 days prior to the assessment time point. | at Week 52 |
Remission at Week 24 | Achievement of remission at Week 24. | at Week 24 |
Time in remission through Week 52 | The duration (in days) in remission to first PMR flare, up to Week 52. | through Week 52 |
Incidence rate of flare through Week 52 | The number of flares and raw incidence rate over the 52-week treatment period. | through Week 52 |
Change from baseline in PMR activity score and its components at Weeks 24 and 52 | PMR activity score is a composite score based on serum inflammatory markers, physician's global assessment of disease activity visual analog scale (VAS), patient's assessment of pain visual analog score (VAS), morning stiffness and shoulder range of motion. | at Weeks 24 and 52 |
Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Short-form 36-item questionnaire (SF-36v2) | The SF-36v2 yields scores for eight domains (Physical Functioning, Role-Physical, Bodily pain, General health, Vitality, Social Functioning, Role-Emotional, and Mental Health), as well as 2 standardized summary scores - the physical component summary (PCS) and mental component summary (MCS). | at Weeks 24 and 52 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
50 Years
अध्ययन के लिए पात्र लिंग
सभी
- Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
- Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg/d prednisone)
- Participants must be willing and able to take prednisone of 15 mg/day at randomization
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Diagnosis of Giant Cell Arteritis (GCA)
- Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
- Inadequately treated hypothyroidism
- Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
- Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)
- Immunosuppressive therapies including systemic corticosteroids
- Malignancy
- Organ transplant recipient
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
रिजेनरॉन फार्मास्यूटिकल्सअध्ययन केंद्रीय संपर्क
संपर्क: Trial Transparency email recommended (Toll free for US & Canada), 800-633-1610, [email protected]
कोई स्थान डेटा नहीं।