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Trial record 2 of 4 for:    Sandoz | Rituxan

GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® (ASSIST-RT)

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ClinicalTrials.gov Identifier: NCT02514772
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : December 28, 2017
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Brief Summary:
The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: GP2013 - A Proposed biosimilar rituximab Biological: Originator rituximab - Rituxan ® or MabThera ® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: GP2013 - proposed biosimilar rituximab
10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14).
Biological: GP2013 - A Proposed biosimilar rituximab
Active Comparator: Originator rituximab - Rituxan ® or MabThera ®
10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14).
Biological: Originator rituximab - Rituxan ® or MabThera ®



Primary Outcome Measures :
  1. Number of Patients Experiencing Anaphylactic Reactions [ Time Frame: Within 24 hours of each study drug infusion: on Day 1 and Day 14 ]

    2006 NIAID/FAAN* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion.

    For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems:

    • Skin/mucosal tissue
    • Respiratory organs
    • Drop of systolic blood pressure (<90 mmHg or variance from baseline >30%) or associated symptoms
    • Gastrointestinal organs were defined as an anaphylactic reaction.

    The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (<90 mmHg or variance from baseline >30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems.

    * NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis Network


  2. Number of Patients Experiencing Hypersensitivity Reactions [ Time Frame: 24 weeks study duration ]
    The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.

  3. Immunogenicity [ Time Frame: 24 weeks study duration ]

    Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization.

    Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis


  4. Number of Patients Experiencing Potential Infusion-Related Reactions [ Time Frame: On the day of and on the day after each study drug infusion (e.g. on study day 1 and 2 for the 1st study drug infusion and on study day 14 and 15 for the 2nd study drug infusion, if the second drug infusion was given on study day 14) ]
    Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria
  • Completed one full treatment course with either Rituxan® or MabThera®
  • Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated with methotrexate

Exclusion Criteria:

  • RA functional status class IV (ACR 1991 revised criteria)
  • Systemic manifestation of RA
  • Positive serology for hepatitis B or hepatitis C infection
  • Active systemic infection
  • History of cancer
  • Known severely immunocompromised state

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514772


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Sponsors and Collaborators
Sandoz
Hexal AG
Investigators
Study Chair: Sandoz Inc. Sponsor GmbH

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT02514772     History of Changes
Other Study ID Numbers: GP13-302
First Posted: August 4, 2015    Key Record Dates
Results First Posted: December 28, 2017
Last Update Posted: December 28, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Rituximab
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents