Phase 4
Completed N=351
A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01382940 ↗Enrolled (actual)
351
Serious AEs
8.6%
Results posted
Feb 2014
Primary outcomePrimary: Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion — 6.5 percentage of participants
Summary
This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion |
6.5 | — |
| SECONDARY Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion |
0.0 | — |
| SECONDARY Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion |
5.9; 0.0 | — |
| SECONDARY Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion |
0.6 | — |
| SECONDARY Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion |
3.9 | — |
| SECONDARY Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion |
0.0 | — |
| SECONDARY Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion |
6.6 | — |
Eligibility Criteria
Key Inclusion Criteria
- Adult patients, ≥ 18 years of age
- Rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987 American College of Rheumatology criteria
- Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept, infliximab, golimumab, or certolizumab)
- Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled, provided their most recent course of RTX occurred over 6 months but no more than 9 months prior to baseline. The RTX dosage must have been two 1000 mg infusions per course administered at the standard approved rate
- Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8 weeks immediately prior to baseline
Key Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following baseline
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Functional class IV as defined by American College of Rheumatology (ACR) criteria
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- Previous serious infusion reaction to any prior biologic therapy
- Known active current or history of recurrent infection
- Evidence of chronic hepatitis B or C infection
- Pregnant or lactating women
- Body weight of > 150 kg
Data sourced from ClinicalTrials.gov (NCT01382940). 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.