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1. Ibrutinib with rituximab for treating Waldenstrom’s macroglobulinaemia (terminated appraisal)

Ibrutinib with rituximab for treating Waldenstrom’s macroglobulinaemia (terminated appraisal) Ibrutinib with rituximab for treating Waldenstrom’s macroglobulinaemia (terminated appraisal) T echnology appraisal guidance Published: 30 October 2019 www.nice.org.uk/guidance/ta608 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Contents Contents Advice 3 Information 3 Ibrutinib with rituximab for treating Waldenstrom’s (...) macroglobulinaemia (terminated appraisal) (TA608) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 3Advice Advice NICE is unable to make a recommendation about the use in the NHS of ibrutinib with rituximab for treating Waldenstrom's macroglobulinaemia in adults because Janssen did not provide an evidence submission. The company has confirmed that it does not intend to make a submission for the appraisal because

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

2. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia

Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia V Venetoclax with rituximab for pre enetoclax with rituximab for previously viously treated chronic lymphocytic leukaemia treated chronic lymphocytic leukaemia T echnology appraisal guidance Published: 27 February 2019 www.nice.org.uk/guidance/ta561 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility (...) equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia (TA561) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

3. Venetoclax (chronic lymphocytic leukaemia; combination with rituximab) - Addendum to Commission A18-81

Venetoclax (chronic lymphocytic leukaemia; combination with rituximab) - Addendum to Commission A18-81 1 Translation of addendum A19-35 Venetoclax (chronische lymphatische Leukämie; Kombination mit Rituximab) – Addendum zum Auftrag A18-81 (Version 1.0; Status: 26 April 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 26 April 2019 1.0 Commission (...) : A19-35 Version: Status: IQWiG Reports – Commission No. 19-35 Venetoclax (chronic lymphocytic leukaemia; combination with rituximab) – Addendum to Commission A18-81 1 Addendum A19-35 Version 1.0 Venetoclax – Addendum to Commission A18-81 26 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Venetoclax (chronic lymphocytic leukaemia; combination with rituximab) – Addendum to Commission

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

4. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma Full Text available with Trip Pro

AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab.A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab (...) was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review.A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous

2019 EvidenceUpdates

5. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: (Abstract)

Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: In the LYM-3002 study, the efficacy and safety of frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) were compared (...) Oncology Group performance status score of 2 or less, who were ineligible for bone marrow transplantation, were randomly assigned (1:1) to receive six or eight 21-day cycles of VR-CAP (intravenous rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and bortezomib 1·3 mg/m2, plus oral prednisone 100 mg/m2) or R-CHOP (intravenous vincristine 1·4 mg/m2 [2 mg maximum], rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, and doxorubicin 50 mg/m2, plus oral prednisone 100 mg/m2

2019 EvidenceUpdates

6. Rituximab (Truxima) - Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia or Rheumatoid Arthritis

Rituximab (Truxima) - Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia or Rheumatoid Arthritis Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity

2019 Health Canada - Drug and Health Product Register

7. Rituximab (Yescarta) - B-cell lymphoma

Rituximab (Yescarta) - B-cell lymphoma Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012

2019 Health Canada - Drug and Health Product Register

8. Polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant

Polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant Dec2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 EUnetHTA Joint Action 3 WP4 Version 1.0, 13 February 2020 Relative effectiveness assessment of pharmaceutical technologies Polatuzumab vedotin in combination with bendamustine and rituximab (...) this assessment Please cite this assessment as follows: EUnetHTA PTJA06. Authoring Team. Polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant. Joint Assessment. Diemen (The Neth- erlands): EUnetHTA; 2020. [date of citation]. 82 pages. Report No.: PTJA06. Available from: https //www.eunethta.eu PTJA06 - Polatuzumab vedotin for relapsed/refractory DLBCL

2020 EUnetHTA

9. Rituximab as Maintenance Treatment in Rheumatoid Arthritis

Rituximab as Maintenance Treatment in Rheumatoid Arthritis Rituximab as Maintenance Treatment in Rheumatoid Arthritis | CADTH.ca Find the information you need Rituximab as Maintenance Treatment in Rheumatoid Arthritis Rituximab as Maintenance Treatment in Rheumatoid Arthritis Last updated: March 29, 2019 Project Number: HO0002-000 - HE0021-000 Product Line: Technology Review Result type: Report This project reviewed the evidence on the administration of repeated courses of rituximab (...) as regularly scheduled treatment or at extended non-regular intervals to prevent relapses or flares in patients who have had an initial response with rituximab. Files CADTH Technology Review: Optimal Use 360 Report Technology Review Published : March 29, 2019 Follow us: © 2019 Canadian Agency for Drugs and Technologies in Health Get our newsletter:

2019 CADTH - Technology Review

10. Disease-modifying treatments for relapsing remitting multiple sclerosis, including rituximab

Disease-modifying treatments for relapsing remitting multiple sclerosis, including rituximab Disease-modifying treatments for relapsing remitting multiple sclerosis, including rituximab. A health technology assessment. - NIPH Search for: Søk Menu To top level Close Infectious diseases & Vaccines Mental & Physical health Environment & Lifestyle Health in Norway Quality & Knowledge Research & Access to data About NIPH Close Disease-modifying treatments for relapsing remitting multiple sclerosis (...) , including rituximab. A health technology assessment. Order Download: Key message We have systematically collected and reviewed the evidence for clinical effectiveness and general safety issues for disease modifying treatments for relapsing remitting multiple sclerosis, synthesised evidence from randomised controlled trials and non-randomised registry-based studies using network meta-regression, and carefully interpreted the findings. We included rituximab in our analysis as it is used off-label

2019 Norwegian Institute of Public Health

11. Skin involvement in systemic sclerosis: rituximab

Skin involvement in systemic sclerosis: rituximab Skin in Skin inv volv olvement in systemic sclerosis: rituximab ement in systemic sclerosis: rituximab Evidence summary Published: 7 March 2017 nice.org.uk/guidance/es7 pathways K Ke ey points y points The content of this evidence summary was up-to-date in March 2017. See summaries of product characteristics (SPC), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Regulatory status: Regulatory status (...) : Rituximab (MabThera, Roche Products Limited) is a monoclonal antibody. Rituximab is licensed in adults for treating non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. It is administered as an intravenous infusion. Rituximab is not licensed for treating systemic sclerosis (or localised scleroderma) and use for this indication is off-label. Ov Overview erview This evidence summary includes 7 studies

2017 National Institute for Health and Clinical Excellence - Advice

12. Rituximab Maintenance Therapy for the Treatment and Management of Rheumatoid Arthritis: A Review of Clinical Effectiveness

Rituximab Maintenance Therapy for the Treatment and Management of Rheumatoid Arthritis: A Review of Clinical Effectiveness Rituximab Maintenance Therapy for the Treatment and Management of Rheumatoid Arthritis: A Review of Clinical Effectiveness | CADTH.ca Find the information you need Rituximab Maintenance Therapy for the Treatment and Management of Rheumatoid Arthritis: A Review of Clinical Effectiveness Rituximab Maintenance Therapy for the Treatment and Management of Rheumatoid Arthritis (...) : A Review of Clinical Effectiveness Last updated: July 4, 2018 Project Number: RC0997-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of rituximab maintenance therapy for the treatment and management of rheumatoid arthritis? Key Message Five non-randomized studies were included in this review, of which three were single-arm studies and two were comparative cohorts. The studies were of poor quality overall

2018 Canadian Agency for Drugs and Technologies in Health - Rapid Review

13. Rituximab Maintenance Therapy for the Management of Granulomatosis with Polyangiitis or Microscopic Polyangiitis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Rituximab Maintenance Therapy for the Management of Granulomatosis with Polyangiitis or Microscopic Polyangiitis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Rituximab Maintenance Therapy for the Management of Granulomatosis with Polyangiitis or Microscopic Polyangiitis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines | CADTH.ca Find the information you need Rituximab Maintenance Therapy for the Management of Granulomatosis with Polyangiitis (...) or Microscopic Polyangiitis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Rituximab Maintenance Therapy for the Management of Granulomatosis with Polyangiitis or Microscopic Polyangiitis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Last updated: July 31, 2018 Project Number: RC1003-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the comparative clinical effectiveness of rituximab

2018 Canadian Agency for Drugs and Technologies in Health - Rapid Review

14. Rituximab for the Treatment of Myasthenia Gravis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Rituximab for the Treatment of Myasthenia Gravis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Rituximab for the Treatment of Myasthenia Gravis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines | CADTH.ca Find the information you need Rituximab for the Treatment of Myasthenia Gravis: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Rituximab for the Treatment of Myasthenia Gravis: A Review of Clinical Effectiveness, Cost (...) -Effectiveness, and Guidelines Last updated: August 14, 2018 Project Number: RC1004-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of rituximab induction therapy for the treatment of myasthenia gravis for those who are refractory to standard therapy? What is the clinical effectiveness of rituximab re-treatment for the treatment of myasthenia gravis? What is the clinical effectiveness of rituximab maintenance

2018 Canadian Agency for Drugs and Technologies in Health - Rapid Review

15. Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab

Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab Obinutuzumab with bendamustine for Obinutuzumab with bendamustine for treating follicular lymphoma refr treating follicular lymphoma refractory actory to rituximab to rituximab T echnology appraisal guidance Published: 30 August 2017 nice.org.uk/guidance/ta472 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility (...) unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab (TA472) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

16. Safety Considerations for the Implementation of Subcutaneous Rituximab Formulation

Safety Considerations for the Implementation of Subcutaneous Rituximab Formulation June 14 th , 2018 Safety Considerations for the Implementation of Subcutaneous Rituximab Formulation Re: Subcutaneous Rituximab Dear Health Care Provider: With the planned implementation of subcutaneous rituximab in Ontario (effective date: August 1, 2018), the Systemic Treatment Program would like to raise awareness of potential safety concerns and mitigation strategies shared by provinces who have adopted (...) this formulation. The implementation of subcutaneous rituximab in facilities who are also using the IV formulation requires careful planning and education to prevent any medication errors between the two products. Based on the experiences that have been shared from other provinces that have implemented subcutaneous rituximab, the Systemic Treatment Program recommends that hospitals address the following issues prior to implementation at their facility(ies): 1. Policy and Procedures Many hospitals have polices

2018 Cancer Care Ontario

17. Ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy (terminated appraisal)

Ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy (terminated appraisal) Ibrutinib with bendamustine and Ibrutinib with bendamustine and rituximab for treating relapsed or rituximab for treating relapsed or refr refractory chronic lymphocytic actory chronic lymphocytic leukaemia after systemic ther leukaemia after systemic therap apy y (terminated appr (terminated appraisal) aisal) T echnology appraisal guidance (...) Published: 22 March 2017 nice.org.uk/guidance/ta437 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Contents Contents Advice 3 Background 4 Information 5 Ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy (terminated appraisal) (TA437) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

18. Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details

Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details | CADTH.ca Find the information you need Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details Project Number pCODR 10180 Brand Name TBD Generic Name Rituximab Strength Tumour Type Lymphoma & Leukemia Indication Non-Hodgkin’s

2019 CADTH - Pan Canadian Oncology Drug Review

19. Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details

Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details | CADTH.ca Find the information you need Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details Project Number pCODR 10162 Brand Name Venclexta in combo Rituximab Generic Name Venetoclax Tumour Type Leukemia Indication Chronic Lymphocytic Leukemia (CLL) Funding (...) Request In combination with rituximab (V+R) is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy Review Status Notification to Implement Issued Pre Noc Submission No NOC Date September 21, 2018 Manufacturer AbbVie Corporation Sponsor AbbVie Corporation Submission Date October 24, 2018 Submission Deemed Complete November 7, 2018 Submission Type New Indication Prioritization Requested Stakeholder Input Deadline ‡ November 7

2019 CADTH - Pan Canadian Oncology Drug Review

20. Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details

Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details | CADTH.ca Find the information you need Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details Project Number pCODR 10184 Brand Name Truxima Generic (...) Name Rituximab Strength 10 mg/mL Tumour Type Lymphoma & Leukemia Indication Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar Funding Request Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Review Status File-Closed Not Submitted Pre Noc Submission No NOC Date April 4, 2019 Manufacturer Teva Canada Innovation Sponsor Teva Canada Innovation Submission Date (Target Date) May 22, 2019 Submission Deemed Complete Submission Type Biosimilar – New Drug Stakeholder Input Deadline

2019 CADTH - Pan Canadian Oncology Drug Review

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