Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas

The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).

开始日期2019-02-14

申办/合作机构

Institut Bergonié

[+2]

NCT03658889 / CompletedN/A

Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France

The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.

开始日期2018-08-02

申办/合作机构

Chugai Pharma France SAS

[+1]

NCT02968979 / CompletedN/A

Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.

The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).

开始日期2016-07-01

申办/合作机构

Chugai Pharma France SAS

[+1]

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0 项与 Chugai Pharma France SAS 相关的专利（医药）

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项与 Chugai Pharma France SAS 相关的文献（医药）

2021-03-01·Rheumatology and Therapy3区 · 医学

Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study

3区 · 医学

ArticleOA

作者: Baillet, Athan ; Barnetche, Thomas ; Fardellone, Patrice ; Roux, Christian ; Saraux, Alain ; Constantin, Arnaud ; Baudens, Guy ; Lespessailles, Eric ; Hilliquin, Pascal ; Flipo, René-Marc ; Shipley, Emilie ; Gilbert-Marceau, Anika ; Idier, Isabelle

INTRODUCTIONDrug retention is particularly relevant to assess long-term treatments. This real-world study mainly aimed to describe 1-year retention rate (RR) of subcutaneously administered tocilizumab (TCZ-SC) in patients with moderate to severe active rheumatoid arthritis (RA).METHODSThis non-interventional, prospective, multicenter study (NCT02608112) was conducted in patients with RA initiating TCZ-SC treatment, with an 18-month follow-up. RR was estimated at month 12 in the overall population and baseline subgroups (combination with a conventional synthetic disease-modifying antirheumatic drug (csDMARD) or not, age, body mass index, methotrexate dose), using the Kaplan-Meier method. Patient compliance to TCZ-SC was described using the 5-item Compliance Questionnaire for Rheumatology (CQR5).RESULTSAt inclusion 75% of the 285 analyzed patients were women, mean RA duration was 9 ± 9 years, previous RA treatments included biological agents (63%) and/or csDMARDs (94%), mean Disease Activity Score 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR) was 4.8 ± 1.2. TCZ-SC RR at month 12 was estimated to be 64% (95% CI 58%-69%) with no statistical differences between subgroups. Clinical results improved with TCZ-SC; the proportion of patients treated with combined glucocorticoids decreased from 49% to 22% at month 12. At each follow-up time, at least 80% of patients were high adherers to TCZ-SC (at least 80% of theoretical injections). Among the 286 patients with at least one TCZ-SC injection, 25 patients (9%) experienced serious adverse events related to TCZ-SC with no differences according to patient age.CONCLUSIONSThis real-world study corroborates the RR at month 12 previously shown in interventional studies on TCZ-SC. Our data suggest there are no differences according to patient's profile (age, BMI), methotrexate doses, and TCZ-SC use.TRIAL REGISTRATIONNCT02608112.

2021-03-01·Annals of the Rheumatic Diseases1区 · 医学

Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial

1区 · 医学

Article

作者: Goupille, Philippe ; Chevalier, Xavier ; Flipo, René-Marc ; Ottaviani, Sébastien ; Latourte, Augustin ; Ornetti, Paul ; Sellam, Jérémie ; Wendling, Daniel ; Piperno, Muriel ; Vicaut, Eric ; Richette, Pascal ; Pers, Yves-Marie ; Eymard, Florent ; Bertola, Jean Pierre ; Fautrel, Bruno ; Peyr, Olivier

ObjectiveTo evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.MethodsThis was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0–100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients’ and physicians’ global assessment and function scores.ResultsOf 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was −7.9 (SD 19.4) and −9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.ConclusionTocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

2020-12-01·Arthritis Research & Therapy2区 · 医学

Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

2区 · 医学

ArticleOA

作者: Lhorte, Pauline ; Perlat, Antoinette ; Ferreira-Maldent, Nicole ; Talib, Zohra ; Vautier, Matthieu ; Cacoub, Patrice ; Lioger, Bertrand ; Quiere, Isabelle ; Delforge, Juliette ; Bleibtreu, Alexandre ; Fain, Olivier ; Connault, Jerome ; Gottenberg, Jacques-Eric ; Vicaut, Eric ; Thietart, Sara ; Bertola, Jean Pierre ; Mekinian, Arsene ; Saadoun, David ; Jego, Patrick ; Savey, Léa ; Limal, Nicolas

AbstractObjectivesTo assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).MethodsProspective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up.ResultsThirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months;p < 0.001), ITAS-2010 score (5 [2–7] versus 3 [0–8];p = 0.002), and ITAS-A score (7 [4–10] versus 4 [1–15];p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.ConclusionTocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary.Trial registrationClinicalTrials.govNCT02101333. Registered on 02 April 2014.

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