Phase 3
Completed N=107
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
Source: ClinicalTrials.gov NCT02514772 ↗Enrolled (actual)
107
Serious AEs
2.8%
Results posted
Dec 2017
Primary outcomePrimary: Number of Patients Experiencing Anaphylactic Reactions — 0; 1 Participants
◆ Published Evidence
Established
28citations · ~4 / year
Brief Report: Safety and Immunogenicity of Rituximab Biosimilar GP 2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis.
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.
Linked Publications
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Brief Report: Safety and Immunogenicity of Rituximab Biosimilar GP 2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing Anaphylactic Reactions |
0; 1 | — |
| PRIMARY Number of Patients Experiencing Hypersensitivity Reactions |
5; 6 | — |
| PRIMARY Immunogenicity |
0; 1 | — |
| PRIMARY Number of Patients Experiencing Potential Infusion-Related Reactions |
4; 7; 2; 5; 6; 10 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02514772) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.