Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to further investigate rituximab in the treatment of rheumatoid arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to improve the evaluation of treatments.

Key facts

Study ID

NCT00425932

Run by

Gaylis, Norman B., M.D.

People needed

60

Starts

2007-02-01

Expected to finish

2012-11-01

Last updated by the study team

2013-08-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to give written informed consent
• Age 18-80 years
• Must have active rheumatoid arthritis for at least 12 weeks, but no more than 5 years.
• Must be receiving treatment on an outpatient basis
• Must have > 8 tender and swollen joints
• Must have negative serum pregnancy test
• Must have an inadequate response to MTX
• Must have elevated serology parameters
• Must have Positive RF or anti-CCP antibody, or radiographic evidence of at least one joint with definite erosion attributable to RA.
• Stable use of Corticosteroids is permitted
• Stable use of NSAIDs is permitted

You may not qualify if…

• History of or current inflammatory joint disease
• Functional class IV
• Any surgical procedure within 12 weeks
• Lack of peripheral venous access.
• Pregnancy or breast feeding.
• Significant cardiac or pulmonary disease.
• Evidence of significant uncontrolled concomitant disease
• Positive HIV
• Known active infection of any kind
• History of deep space/tissue infection
• History of recurrent significant infection
• Concomitant malignancies or previous malignancies
• Any neurological, vascular or systemic disorder
• History of drug, alcohol, or chemical abuse
• Inability to comply with study and follow-up procedures
• History of a severe allergic or anaphylactic reaction to a biologic agent
• Previous treatment with more than one biologic agent for RA. Patients must not have received a biologic agent within 2 months prior to the Baseline visit, except for etanercept, abatacept and anakinra for which a one month washout prior to Baseline visit is acceptable
• Previous treatment with an anti-alpha 4 integrin antibody or co-stimulation modulator.
• Previous treatment with any cell depleting therapies.
• Treatment with any investigational agent within 28 days
• Receipt of a live/attenuated vaccine within 28 days
• Ongoing use of high dose steroids (>10mg/day)
• Inra-articular or parental glucocorticoids within 4 weeks prior to baseline.
• Intolerance or contraindications to i.v. glucocorticoids.

Where it is running

• Guillermo Valenzuela MD — Fort Lauderdale, Florida, United States
• Drs. Charles Kahn and Wayne Riskin — Hollywood, Florida, United States
• Arhtritis & Rheumatic Disease Specialties — Miami, Florida, United States
• Arthritis and Rheumatology Clinics of Kansas — Wichita, Kansas, United States
• McBride Clinic Orthopedic Center — Oklahoma City, Oklahoma, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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