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  • PICO Venous Leg Ulcers (VLU) Reimbursement Study

    This is a national, multicentre, pragmatic, randomized, controlled superiority study in which PICO treatment with compression therapy will be compared against Standard of Care (i.e. traditional wound dressings with compression therapy). There will be two parallel treatment arms with a 1:1 allocation ratio and a stratification on wound duration and size. There will be an additional blind assessment for the primary outcome measure. Approximately 37 investigational sites located in France will be enrolled. At each site, a community-based practitioner (general practitioner or specialist) will be enrolled as Principal Investigator (PI). District nurses will be responsible for providing wound care in homecare setting. Duly informed and eligible patients will complete an inclusion visit after which they will enter in a 2-week run-in period in which subjects will be treated with standard of care. After these 2 weeks of run-in, eligibility to randomization will be assessed using pre-specified criteria listed in the protocol, that aim to confirm that the wound does not respond to an adequately conducted standard of care in a satisfactory manner, including subject compliance with compression therapy. Upon randomization, baseline data will be collected, and each subject will be followed-up by the PI for 12 weeks. The PI will conduct 3 visits, i.e., at Week 4 (D28±3 days), Week 8 (D56±3 days), and Week 12 (D84±3 days). Relevant study data will be collected at these visits. In the event wound healing is observed during the 12-week follow-up period of the study either by the PI or by the home care nurse, a Wound Healing Confirmation Visit needs to be conducted with the PI 2 weeks later (±3 days) to confirm that the wound is still healed. Only wounds still healed at the wound healing confirmation visit will be counted as "healed" in the primary endpoint analysis. This means that for wounds that are not healed by Week 12, the visit with the PI at Week 12 will be the final study visit for the subject. Following, because a Wound Healing Confirmation Visit needs to be conducted 2 weeks (±3 days) following the initial observation of wound healing, which can occur at any time throughout the 12 week follow-up period, the Wound Healing Confirmation Visit can occur at any time as well, but at the latest 2 weeks (±3 days) following the visit at Week 12, i.e. at week 14±3 days. In between study visits with the PI, patients are cared for at home by their home care nurse who will also be trained on the study. The study nurse will be collecting study related data as well using a secure mobile application.

    Phase

    N/A

    Span

    122 weeks

    Sponsor

    Smith & Nephew, Inc.

    Cahors

    Recruiting

  • Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

    This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated Follicular Lymphoma International Prognostic Index (FLIPI) 2-5 follicular lymphoma This study is composed of a screening period (up to 6 weeks before randomization, i.e., 42 days), a treatment period (30 months i.e., 125w), a safety follow-up period (90 days i.e., 3 months), and a survival follow-up period (up to 7 years after the last randomized patient). The enrollment will last approximately 34 months. The total duration of the study will be therefore approximately 10 years. Once a patient provides written consent, they may enter the screening phase, with a duration up to 6 weeks prior to randomization and initiation of treatment. Upon completion of the required assessments in the screening phase, and fulfillment of the eligibility criteria, patients will be randomized. Investigators will be requested to indicate their treatment choice among permitted immuno-chemotherapy regimens just before randomization. The treatment period for each patient starts with the first intake. The patients will receive protocol-specified treatments until: - inability to achieve a response at the end of induction phase (at M12 evaluation for experimental arm, and at M6 evaluation for control arms), - relapse or progression of the disease, - withdrawal of consent, - or unacceptable toxicity In the experimental arm, patients will be treated for 1 cycle of 3 weeks for mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide (47 weeks, around 11 months) during the induction phase, and for a maximum of 9 additional cycles of 8 weeks during the maintenance phase (72 weeks, around 17 months), up to around 125 weeks (30 months). Patients should start the maintenance phase 7 to 8 weeks after the start of last induction cycle (C12). In the control arm, patients will be treated for 8 or 6 cycles of 3 or 4 weeks for anti-CD20 mAb +cyclophosphamide-doxorubicine-vincristine-prednisone (CHOP) or anti-CD20 mAb + Bendamustine, respectively, depending on the assigned arm (24 weeks, around 5 months) during the induction phase, and for a maximum of 12 additional cycles of 8 weeks during the maintenance phase (96 weeks, around 22 months), up to around 125 weeks (30 months). Patients should start the maintenance phase, 6 to 7 or 7 to 8 weeks after the start of last induction cycle (C8 or C6). The option to cross-over from the control arm to the experimental arm is not allowed. All randomized patients will be followed for progression-free survival and overall survival using the same schedule. Patients will be followed up from End of treatment evaluation every 3 months during the first two years, then every 6 months during the next 3 years, then yearly until the end of study. The end of study will occur when all randomized patients have been followed-up for survival for at least 7 years (or discontinued study early).

    Phase

    3

    Span

    517 weeks

    Sponsor

    The Lymphoma Academic Research Organisation

    Cahors

    Recruiting

  • Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France

    This is a non-interventional, prospective (primary data), multicenter study conducted in metropolitan France. The primary objective of this study is to describe the quality of life of MS patients after initiation of treatment with ofatumumab. In order to form a representative sample of MS patients taking into account the terms of care in France, free or practicing neurologists in healthcare institutions (public or private) in different regions of France will be selected to participate in this study. The study will enroll adult patients with MS who initiated ofatumumab according to the physician's advice and independently of the study. Patients will be followed from initiation of ofatumumab either until (i) 12 months (± 1month) after initiation of ofatumumab (End of Study), or until (ii) discontinuation of treatment with ofatumumab prior to the completion of the 12-month follow-up (early termination); whichever occurs first (end of study or early termination).

    Phase

    N/A

    Span

    137 weeks

    Sponsor

    Novartis Pharmaceuticals

    Cahors

    Recruiting

  • SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases

    In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions. - Primary objective: to define predictive factors for the persistence of treatment - Secondary objectives: - To assess the therapeutic benefit and the tolerability of the treatment - To describe the reasons for treatment discontinuations occurring during follow-up

    Phase

    N/A

    Span

    162 weeks

    Sponsor

    Fresenius Kabi, France

    Cahors

    Recruiting

  • Retrospective Study of COVID-19 Vaccines in Patients Undergoing Immunotherapy for Cancer.

    The recent outbreak of Coronavirus 2019 (COVID-19) caused by a new zoonotic coronavirus SARS-Cov-2 poses a major public health threat, with at least 100,000,000 people infected worldwide by the end of January 2021 and over 2 million deaths. Given the scale of the pandemic, it has become imperative to quickly develop a vaccine and over 30 vaccine candidates have entered clinical evaluation. The first vaccine to receive marketing authorization in Europe and France was an mRNA vaccine, Comirnaty® (Bnt162b2; Pfizer/BioNtech). In a Phase III study of 43,448 participants, after a median follow-up of 2 months, the number of cases of COVID-19 was 8 in the vaccine arm vs. versus 162 in the placebo arm, respectively, with 1 versus 9 serious cases (Polack et al. 2020). Adverse events occurred in more than 50% of vaccinated participants and included local reactions as well as frequent systemic reactogenicity such as fatigue and headache. Fever occurred in about 15% of the participants who received the vaccine. The second vaccine to be licensed was also an mRNA vaccine: the Moderna COVID-19 mRNA (nucleoside modified) vaccine (mRNA-1273, Moderna). A Phase III trial involving 30,420 volunteers reported efficacy and safety comparable to the Pfizer/BioNtech vaccine. A severe form of COVID-19 occurred in 30 subjects, with one death; all 30 cases were in the placebo group. Moderate and transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare and the incidence was similar in both groups. Within the vaccination strategy implemented on a national level, the Comirnaty® vaccine (Pfizer/BioNtech) and the Moderna COVID-19 mRNA vaccine (nucleoside modified) may be used interchangeably, depending on logistical constraints. For several weeks now, the Oxford-AstraZeneca chimpanzee adenovirus vector vaccine ChAdOx1 nCoV-19 (AZD1222) has been available in France and its efficacy and safety of use have been evaluated. Also the non-replicating viral vector (adenovirus) vaccine for CVD 19 from Janssen Laboratories (a subsidiary of Johnson & Johnson; other names: Ad26COV2.S; JMJ Vaccine or J & J COVID-19 Vaccine) was launched in France a few weeks ago. Its efficacy and safety have been validated in a phase III trial. A number of other candidate vaccines using various techniques such as mRNA, protein subunit, viral vector or inactivated vaccines are currently under investigation and will be available soon. Cancer patients are particularly at risk of developing a severe form of COVID-19. Patients with solid tumors appear to be at a greater risk, particularly in the first year after diagnosis. Severity and mortality rates in the COVID-19 and Cancer Consortium (CCC19) registry and other cohorts range from 5% to 61% (a meta-analysis showed 26%), which is well above the general population. Although data on vaccination in cancer patients are limited, there is sufficient evidence to support anti-infective vaccination in general, even in cancer patients on immunosuppressive therapy. In its notice dated January 25th, 2021, the National Cancer Institute defined its recommendations for prioritizing cancer patients for vaccination against SARS-CoV-2. This report stresses that the data acquired from science is limited in quantity and quality concerning the emerging field of vaccination against SARS-CoV-2 and even more so in sub-populations including cancer patients. It reminds us that the challenge remains to vaccinate the entire population of patients who have or have had cancer, i.e. approximately 3.8 million people. The level of efficacy can be expected to be generally reduced in certain cancer patient populations with intense immunosuppression, such as haematopoietic stem cell transplant recipients. However, based on extrapolation of data from other vaccines and the mechanism of action of COVID-19 (non-live) vaccines, it is conceivable that the efficacy and safety of COVID-19 vaccination could be estimated to be similar to that of non-cancer patients, although data from clinical trials are lacking. The efficacy and duration of immunity in cancer patients is still unknown and unexplored. It is therefore legitimate to propose surveillance through dedicated registries and clinical trials. Furthermore, close monitoring and follow-up of cancer patients is required after COVID-19 vaccination to assess potential adverse events and measure clinical outcomes, e.g. infection, severity and mortality from COVID-19, cancer complications etc… The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. Our hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.

    Phase

    N/A

    Span

    137 weeks

    Sponsor

    Centre Hospitalier Universitaire de Nīmes

    Cahors

    Recruiting

  • Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use

    PERSON-AL is a multicentric, interventional, open-label, randomized, parallel-group, stratified by centre, study comparing two arms: usual care versus intervention (personalized care preceded by a standardized assessment) Principal Objective : To evaluate the impact of a personalized intervention for the management of agitation due to psycho-behavioral symptoms on the use of scheduled and unscheduled hospitalizations at 18 months in patients with AD and related disorders. Secondary Objectives: A- To evaluate the impact of a personalized intervention at 18 months on: For the patient: 1. Unscheduled hospitalizations, 2. Severity of agitation symptoms, 3. The frequency and severity of emerging psycho-behavioral symptoms, other than agitation, 4. Prescription of psychotropic drugs, 5. Quality of life. For the caregiver: 6. Distress related to psycho-behavioral symptoms, 7. All causes hospitalizations, 8. Quality of life. B- Evaluate the medico-economic impact of this personalized intervention, and in particular: 1. Its efficiency compared to usual management by means of cost-effectiveness and cost-utility analyses, from the community perspective and over a time horizon of 18 months, 2. The actual cost of patient's standardized assessment and personalized management 3. The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    University Hospital, Toulouse

    Cahors

    Recruiting

  • A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer

    Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite stability (MSS) / proficient mismatch repair (pMMR) tumor. The overall survival and access to different treatment in the real-life setting are unknown. Moreover, patient prognosis remains poor and therapeutic resistance to combinations with BRAF inhibitors, is at present, nearly universal. Therefore, it seems essential to prospectively collect clinical and biological data about this rare mCRC subtype. These data will allow us to improve knowledge and to identify clinical and biological factors that could drive therapeutic decisions, predict resistance to treatments, and that are prognostic for survival. In this context, we designed this large, prospective, cohort study to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with BRAFV600E mCRC. This collection of clinical and biological data (tumor tissue and blood samples) will allow us to identify predictive and prognostic biomarkers with several research work packages planned: i. To evaluate the circulating tumor DNA (ctDNA) during the metastatic first-, second-, and third-line treatment to: - Evaluate its positive and negative predictive value. - Identify molecular alterations preceding and explaining clinical resistance during BRAF/EGFR inhibition therapy and immunotherapy. ii. To evaluate BRAFV600E mCRC immune environment both at the tumor and blood level (immunomonitoring). iii. To study specific the dMMR/MSI BRAFV600E subgroup. Furthermore, the data collected will describe the therapeutic management of BRAFV600E mCRC patients in the routine-practice setting which will bring very useful data. The results of the COBRAF study could lay the groundwork to better understand BRAFV600E mCRC and to identify prognostic and predictive biomarkers helping the development of new therapeutic approaches in this population.

    Phase

    N/A

    Span

    262 weeks

    Sponsor

    UNICANCER

    Cahors

    Recruiting

  • Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

    In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX) (1). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological (b) DMARD (TNF inhibitors, anti-IL6, abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered. Current practice is to start a bDMARD and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial). Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues. This is the first study to propose a therapeutic sequential strategy with an induction therapy using a TNF inhibitor for 12 weeks to control inflammation followed by a cell-targeted biological DMARD targeting T cells (abatacept) in order to decrease auto-antibodies (rheumatoid factor and/or ACPA). Presence of auto-antibodies (ACPA/RF) are predictive of better response to cell- targeted DMARDs. In early AMPLE trial, RA patients ACPA+ with insufficient response to MTX were treated with abatacept or adalimumab. DAS28-CRP remission rates were 55% in abatacept group and 30% in adalimumab group. Patients carrying the shared epitope (HLA-DR (Human Leucocyte Antigen-DR) alleles associated with RA), were also more likely to reach remission (DAS28-CRP<2.6) with abatacept (50%) than adalimumab (23%) at 24 weeks. The clinical trial offered by investigateors here could change the paradigm in the strategy used in RA supporting the importance to first control inflammation environment in order to allow the cell-targeted bDMARDs to control immunological process which has been recently associated with a higher percentage of clinical remission. To compare the percentage of remission (DAS28-CRP<2.6) obtained during the 36 weeks following randomization, with a sequential therapeutic strategy using abatacept versus a routine strategy continuing TNF inhibitors (TNFi), in ACPA positive RA patients responding to a first TNFi, initiated 12 weeks before randomization. The primary endpoint will be analyzed with a generalized estimating equations (GEE) model for repeated data. It is a multicentric, open label, randomized controlled trial comparing two different strategies of treatment with an independent efficacy assessor. For this clinical trial, to limit response bias, bDMARDs with a similar mode of administration (subcutaneous) are proposed. In the experimental arm, a therapeutic sequential strategy will be proposed and in the control arm TNF inhibitors will be proposed for 48 weeks. All included patients will receive TNF inhibitors subcutaneous for 12 weeks. At 12 weeks (W12), patients who have at least a moderate EULAR response (delta DAS28-CRP between W0 and W12>0.6 and DAS28-CRP≤5.1 at W12) will be randomized with a 1:1 ratio in the sequential strategy arm or the control arm. In the sequential strategy arm, the 88 randomized RA patients will be switched to abatacept subcutaneous for 36 weeks. Patients who will withdraw abatacept during the follow-up will be considered as a failure. In the control group, the 88 randomized RA patients will be treated with TNF inhibitor subcutaneous for another 36 weeks. In case of insufficient response to a first TNF inhibitor at 24 or 36 weeks, a second TNF inhibitor will be proposed. Anti-TNF drugs withdrawal will be considered as a failure. Steroids 0.1mg/kg/ day will be allowed but at stable dose 2 weeks before and with guided step-down strategy targeting withdrawal before 24 weeks following randomization. Clinical evaluation of disease activity using different scores (DAS28-ESR, CDAI, SDAI, Boolean criteria) and tolerance will be performed at all visits.

    Phase

    3

    Span

    262 weeks

    Sponsor

    University Hospital, Montpellier

    Cahors

    Recruiting

  • Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis

    This is a multicenter single-arm clinical study including male and female subjects with moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy as determined by the physician. A total of 30 subjects are anticipated and will be enrolled in 10 study sites in France. The patients will receive intravesical instillations with INSTYLAN weekly for 6 weeks. The objectives of the study are to assess the efficacy of intravesical instillations of INSTYLAN on the basis of hemorrhagic cystitis symptoms disappearance. The primary endpoint is the evaluation of pain using a verbal rating scale one week and four weeks after treatment versus Baseline.

    Phase

    N/A

    Span

    63 weeks

    Sponsor

    LIDDE Therapeutics

    Cahors

    Recruiting

  • Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

    TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.

    Phase

    N/A

    Span

    291 weeks

    Sponsor

    Pfizer

    Cahors

    Recruiting

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