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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00580229
Date of registration: 18/12/2007
Prospective Registration: Yes
Primary sponsor: University of South Florida
Public title: A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Scientific title: A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Date of first enrolment: December 2007
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00580229
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2/Phase 3
Countries of recruitment
United States
Contacts
Name:     John D. Carter, M.D.
Address: 
Telephone:
Email:
Affiliation:  University of South Florida
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: prednisone
Primary Outcome(s)
Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion [Time Frame: 24 hours]
Secondary Outcome(s)
Adverse Events Assessed From Day 15 Through Week 26. [Time Frame: 24 weeks]
Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion. [Time Frame: 24 hours]
Secondary ID(s)
U4164s
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/10/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00580229
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