A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Information source: University of South Florida
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: prednisone (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of South Florida Official(s) and/or principal investigator(s):
John D. Carter, M.D., Principal Investigator, Affiliation: University of South Florida
Overall contact:
John D Carter, M.D., Phone: (813) 974-2681, Email: jocarter@health.usf.edu
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.
Clinical Details
Official title: A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Study design: Treatment, Open Label, Active Control, Single Group Assignment, Safety Study
Primary outcome: The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in RA. This will be determined by assessing all acute infusion reactions in the first 24 hours following the patient's very first infusion (i.e. at baseline).
Secondary outcome: All adverse events (AE's) within 24 hours following the first infusion.All acute infusion reactions with 24 hours following the second infusion. All AE's within 24 hours following the second infusion. All AE's through week 26. HAQ-DI DAS-28
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab (MabThera® / Rituxan®)
- Previous treatment with Natalizumab (Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies
- History of recurrent significant infection or history of recurrent bacterial
infections
- Known active bacterial, viral fungal mycobacterial, or other infection (including
tuberculosis or atypical mycobacterial disease, but excluding fungal infections of
nail beds) or any major episode of infection requiring hospitalization or treatment
with i. v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks
prior to screening
- Ongoing use of high dose steroids (>10mg/day) or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum pregnancy test should be performed for all women of
childbearing potential within 7 days of treatment) or lactation
- Concomitant malignancies or previous malignancies within 5 years, with the exception
of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in
situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in
this protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complications
- Inability to comply with study and follow-up procedures
Locations and Contacts
John D Carter, M.D., Phone: (813) 974-2681, Email: jocarter@health.usf.edu
University of South Florida, Tampa, Florida 33612, United States; Recruiting
Nancy Albritton, LPN, Phone: 813-974-8206, Email: nalbritt@health.usf.edu
John D. Carter, M.D., Principal Investigator
Arthritis Research of Florida, Inc., Palm Harbor, Florida 34684, United States; Recruiting
Ginger Pfeiffer, R.N., C.C.R.C, Phone: 727-210-2555, Email: studies@tampabay.rr.com
Anthony I. Sebba, M.D., Principal Investigator
Additional Information
Starting date: December 2007
Ending date: March 2011
Last updated: February 19, 2009
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