A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

NCT00580229 | Completed Phase 2 Results

• 1 other identifier: U4164s
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

Rituxan; Rituximab

Outcome Measures

Primary Outcomes (1)

• Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion

  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

  24 hours

Secondary Outcomes (2)

• Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.

  24 hours

• Adverse Events Assessed From Day 15 Through Week 26.

  24 weeks

Study Arms (1)

prednisone

EXPERIMENTAL

Prednisone 40mg by mouth 30-60 minutes prior to rituximab.

Drug: prednisone

Interventions

prednisone DRUG

prednisone 40mg by mouth 30-60 minutes prior to rituximab

Also known as: Rayos

prednisone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

Arthritis Research of Florida, Inc.

Palm Harbor, Florida, 34684, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

An area of weakness to the study was the lack of direct comparison group.This was a single university study with two sites the cost,practicality of performing a noninferiority trial comparing these two pretreatment strategies was not feasible.

Results Point of Contact

• Title: John D. Carter, M.D.
• Organization: University of South Florida

jocarter@health.usf.edu

813-974-2681

Study Officials

• John D. Carter, M.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 26, 2018
• Results First Posted: October 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)