Status:
TERMINATED
Stem Cell Support in Patients With Rheumatoid Arthritis
Lead Sponsor:
Richard Burt, MD
Conditions:
RHEUMATOID ARTHRITIS
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Rheumatoid arthritis (RA) is a chronic illness, immunologically mediated, probably induced by the exposure to an antigen or antigens, to which immunologic tolerance is lost. The disease has a variable...
Eligibility Criteria
Inclusion
- Physiologic age \< 60 years old or \>18 years old.
- An established clinical diagnosis of rheumatoid arthritis by American College of Rheumatology criteria, and a positive rheumatoid factor will be required.
- Patients must have failed two disease-modifying agents, such as methotrexate, plaquenil, gold, azathioprine, asulfidine or D-penicillamine.
- Patients must have six (6) swollen joints from active RA and either thirty (30) or greater involved joints (swelling, tenderness, deformity, pain on motion, or decreased motion), or have answered less than 75 percent of Health Assessment Questionnaire (HAQ) questions "without any difficulty."
- A harvest of PBSC greater than 1.4 x 106 CD34+ cells /kg after CD34+ selection will be necessary for the patient to proceed to transplant.
- Ability to give informed consent
- Patients with Juvenile Rheumatoid Arthritis (JRA) will be candidates if disease onset is polyarthritic or systemic and they have at least 6 swollen joints and have failed corticosteroids and two disease-modifying drugs
Exclusion
- HIV positive
- History of coronary artery disease, or congestive heart failure.
- Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemoradiotherapy
- Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
- Positive pregnancy test, inability or unwillingness to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
- FEV1/FVC \< 75% of predicted, DLCO \< 50% of predicted.
- Resting LVEF \< 45 %
- Bilirubin \> 2.0 mg/dl, transferase (AST) \> 2x upper limit of normal
- Serum creatinine \> 2.0 mg/dl
- Platelet count less than 100,000/ul, ANC less than 1000/ul
- History of allergy to eggs or murine proteins
- Known hypersensitivity to E. coli derived proteins
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00278551
Start Date
June 1 1997
End Date
November 1 2011
Last Update
April 8 2013
Active Locations (1)
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1
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611