A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Overview
- Phase
- Phase 2
- Intervention
- prednisone
- Conditions
- Rheumatoid Arthritis
- Sponsor
- University of South Florida
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will be an open-label prospective analysis of oral prednisone (compared to IV methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis. The study will be useful as pilot data to establish that there are no different trends between the two treatment strategies at decreasing the frequency and severity of acute infusion reactions. It would also establish proof of principle that pre-treatment with oral prednisone is equally as efficacious as IV methylprednisolone.
The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in RA.
By showing that there are no differences in the frequency or severity of acute infusion reactions after rituximab when using pre-treatment with oral prednisone compared to I.V. methylprednisolone, we will establish proof of principle that oral prednisone is a viable alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a practical advantage for both the patient and the treating physician. The patient could self-administer this treatment at home thereby decreasing the time they would need to spend at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of methylprednisolone.
Detailed Description
This study will be an open-label prospective analysis of oral prednisone (compared to IV methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis. The study will be useful as pilot data to establish that there are no different trends between the two treatment strategies at decreasing the frequency and severity of acute infusion reactions. It would also establish proof of principle that pre-treatment with oral prednisone is equally as efficacious as IV methylprednisolone. The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in RA. By showing that there are no differences in the frequency or severity of acute infusion reactions after rituximab when using pre-treatment with oral prednisone compared to I.V. methylprednisolone, we will establish proof of principle that oral prednisone is a viable alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a practical advantage for both the patient and the treating physician. The patient could self-administer this treatment at home thereby decreasing the time they would need to spend at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of methylprednisolone..
Investigators
Eligibility Criteria
Inclusion Criteria
- •American College of Rheumatology Criteria for Rheumatoid Arthritis
- •Age 18-80
- •Concomitant methotrexate (MTX) \[oral or parenteral at any dose\]
- •IgG \& IgM levels above lower limit of normal.
- •Adequate renal function as indicated by serum creatinine of \< or = 1.8
- •Study subjects can be either MTX-inadequate responders or TNF-alpha antagonists inadequate responders
- •Able and willing to give written informed consent and comply with the requirements of the study protocol
- •Negative serum pregnancy test (for women of child bearing age)
- •Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
- •If patients are on corticosteroids, they must be on a dose of \< or = to prednisone 10mg oral daily (or its equivalence) and the dose must remain stable for 4 weeks prior to their first rituximab infusion.
Exclusion Criteria
- •An inflammatory arthritis other than RA
- •ANC \< 1.5 x 103
- •Hemoglobin: \< 8.0 gm/dL
- •Platelets: \< 100,000/mm
- •AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.
- •Positive Hepatitis B or C serology (Hep B Surface antigen and Hep C antibody)
- •History of positive HIV (HIV conducted during screening if applicable)
- •Treatment with any TNF-alpha antagonist within 8 weeks of Day 1 visit (for infliximab and adalimumab) or 4 weeks (for etanercept).
- •Previous treatment with abatacept (Orencia) at any time.
- •Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
Arms & Interventions
prednisone
Prednisone 40mg by mouth 30-60 minutes prior to rituximab.
Intervention: prednisone
Outcomes
Primary Outcomes
Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion
Time Frame: 24 hours
Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion
Secondary Outcomes
- Adverse Events Assessed From Day 15 Through Week 26.(24 weeks)
- Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.(24 hours)