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18 Years
65 Years
Open (Enrolling)
Rheumatic Diseases

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Trial Information

Inclusion Criteria:

- Patients are required to meet the criteria of the American College of Rheumatology
(ACR)for rheumatoid arthritis.

- Patients should be in functional class II, or III according to the criteria of the

- All candidates must be unsuccessfully treated (lack of efficacy) with at least two of
the following disease-modifying antirheumatic drugs: hydroxychloroquinine, oral or
injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine.

- Patients receiving nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids (<=
10 mg per day), or both are eligible if the dosage has been stable for at least four
weeks before treatment and remained so throughout the study and follow-up period (the
use of narcotics for pain flares is allowed).

- The necessary degree of disease activity at enrollment should be confirmed by a
finding of 10 or more swollen joints, 12 or more tender joints, and one of the
following two criteria: a Westergren erythrocyte sedimentation rate of at least 28 mm
per hour or a serum C-reactive protein level of more than 2.0 mg per deciliter; or
morning stiffness for at least 60 minutes.

- Patients must have adequate bone marrow function, adequate liver function, adequate
renal function, calcium and electrolytes.

- Patients must have a dobutamine stress ECHO, or exercise cardiac MUGA, or exercise
ECHO scan prior to entry and must fulfill certain criteria to be eligible. The spirit
of the criteria are to rule out organic heart disease.

- Respiratory status: Patients who have FEV1 of >= 60% of predicted, as well as a
maximum voluntary volume (MVV) of >= 60% of predicted, and blood gases with a PO2 of
>= 60 or oxygen saturation of >= 90% are eligible.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Rheumatic Diseases
  • Rheumatoid Diseases
  • Rheumatic Diseases



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