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

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Gaylis, Norman B., M.D.
Study ID
NCT00425932
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    At Week 24 or any time up to Week 48 if the Patient DAS 28 \> 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.

Study Details

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 Dates

Start date
Feb 28, 2007
Status verified
Aug 2013
Primary completion
Nov 30, 2011
Completion
Nov 30, 2012

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Rituximab/Placebo
    Patients will be randomized at Baseline to either Placebo or Rituximab. At Week 24 and up to Week 48 if patient DAS28 score is \>2.6, patient will be retreated with open label Rituximab.
  • Active Comparator: Open Label
    At Week 24 or any time up to Week 48 if the Patient DAS 28 \> 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.

Primary Outcome Measure

The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24. [ Time Frame: 24 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Guillermo Valenzuela MDFort LauderdaleFlorida33324-
Drs. Charles Kahn and Wayne RiskinHollywoodFlorida33021-
Arhtritis & Rheumatic Disease SpecialtiesMiamiFlorida33180-
Arthritis and Rheumatology Clinics of KansasWichitaKansas67220-
McBride Clinic Orthopedic CenterOklahoma CityOklahoma73103-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-

Find similar trials in Fort Lauderdale, FL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Guillermo Valenzuela MD· Fort Lauderdale, FLDrs. Charles Kahn and Wayne Riskin· Hollywood, FLArhtritis & Rheumatic Disease Specialties· Miami, FLArthritis and Rheumatology Clinics of Kansas· Wichita, KSMcBride Clinic Orthopedic Center· Oklahoma City, OKOklahoma Medical Research Foundation· Oklahoma City, OK

Related Studies