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Completed

NCT Number: NCT02514772

GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Praxis Prof. Herbert Kellner, München, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GP2013 - A Proposed biosimilar rituximab

Biological

Originator rituximab - Rituxan ® or MabThera ®

Biological

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Hexal AG

Registry information

Official study 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®

Acronym: ASSIST-RT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2015
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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