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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.
Last refreshed on: 8 August 2016
Main ID:  NCT00282412
Date of registration: 24/01/2006
Prospective Registration: No
Primary sponsor: Northwestern University
Public title: Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism
Scientific title: Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism
Date of first enrolment: September 2002
Target sample size: 4
Recruitment status: Terminated
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Name:     Richard Burt, MD
Affiliation:  Northwestern University
Key inclusion & exclusion criteria

Participant Inclusion Criteria:

- Age > 18 and < 60 years at time of pre-transplant evaluation.

- An established clinical diagnosis of rheumatoid arthritis by American College of
Rheumatology criteria.

- Patients must have failed an autologous hematopoietic transplant or have failed to
respond to either methotrexate or leflunomide in combination with a TNF inhibitor.
Failure is defined as an inability to tolerate treatment with at least 6 swollen
joints and 20 involved joints or inability to answer at least 70% of HAQ questions
with "no difficulty" despite 2 or more months of treatment.

- Ability to give informed consent.

- Patient must have a HLA matched sibling donor at the A, B, C, and DR loci to
proceed or HLA matched cord blood donor.

- If donor is HLA matched cord blood, cord blood stem cells will be obtained from
the NMDP (1-800-548-1375) and one or two units of HLA matched cord blood will be
infused on day zero.

Participant Exclusion Criteria

- History of coronary artery disease, or documented congestive heart failure.

- HIV positive.

- Uncontrolled diabetes mellitus, or any other illness that in the opinion of the
investigators would jeopardize the ability of the patient to tolerate aggressive

- 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 < 70% of predicted, DLCO < 40% of predicted.

- Resting LVEF < 45 %.

- Bilirubin > 2.0 mg/dl (unless due to Gilberts), transferase (AST) > 2.5 x upper limit
of normal.

- Serum creatinine > 2.0 mg/dl.

Donor Exclusion Criteria

- Age < 18 years.

- Positive for HIV-1, HIV-2, HTLV-I, HTLV-II.

- Active hepatitis B or C.

- History of a malignancy except for a localized cancer such as skin cancer that is
deemed cured.

- History of myocardial infarction or congestive heart failure.

- Inability to give informed consent.

- Current pregnancy.

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Biological: Hematopoietic Stem Cell Transplantation
Primary Outcome(s)
Tender joint count;Swollen joint count; Patient's global assessment of disease;Patient's assessment of pain;Patient's assessment of physical activity; (Health Assessment Questionnaire [HAQ]); Acute phase reactant value (erythrocyte sedimentation rate). [Time Frame: 5 years after transplant]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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