Phase 2 N=24 Diagnostic

Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00147966 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Mar 2010

Primary outcome: Primary: American College of Rheumatology (ACR) 20 at Week 12 — 12 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY American College of Rheumatology (ACR) 20 at Week 12	12	—

Summary

Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

Eligibility Criteria

Inclusion Criteria

Active rheumatoid arthritis
Use of concomitant methotrexate

Exclusion Criteria

Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
Serious medical conditions that would preclude the use of the treating agent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00147966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.