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History of Changes for Study: NCT00425932
Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis
Latest version (submitted August 21, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 22, 2007 None (earliest Version on record)
2 May 17, 2007 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 April 24, 2008 Arms and Interventions, Study Status, Outcome Measures, Study Design and Sponsor/Collaborators
4 June 17, 2011 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Sponsor/Collaborators and Eligibility
5 March 11, 2013 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Study Design
6 August 21, 2013 Study Status
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Study NCT00425932
Submitted Date:  January 22, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: U3900s
Brief Title: Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis
Official Title: Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2007
Overall Status: Not yet recruiting
Study Start: February 2007
Primary Completion:
Study Completion: February 2009
First Submitted: January 22, 2007
First Submitted that
Met QC Criteria:
January 22, 2007
First Posted: January 24, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 22, 2007
Last Update Posted: January 24, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gaylis, Norman B., M.D.
Responsible Party:
Collaborators: Ewa Olech, M.D.
Genentech, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:

Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin's B cell lymphoma (a type of cancer) and for certain patients with rheumatoid arthritis (RA) by the Food and Drug Administration (FDA). To date, more than 1000 subjects with rheumatoid arthritis have received rituximab in clinical studies.

Magnetic resonance imaging (MRI) is a modern and sensitive method of looking at joints in people with rheumatoid arthritis. It uses a magnetic field to create an image. The MRI takes an image in 3 dimensions and this provides a better picture for a physician to see more details.

There are two treatment groups in this study with equal numbers of patients assigned to each group. All the patients will receive their baseline Methotrexate and two intravenous infusions 2 weeks apart of one of the following:

  • 1000 mg rituximab or
  • placebo. Patients outcomes will be compared between the 2 groups. After week 24 (open label phase), the patients will receive rituximab if rheumatoid arthritis remains active.

All the patients will have MRI of their dominant hand and wrist with and without gadolinium performed at baseline, 12, 24 and 48 weeks on 1.5 Tesla MRI . Some patients will also have additional MRI of the same hand and wrist without gadolinium at the same time points on 0.2 Tesla MRI. Comparison of the images from the two machines will be performed.

Various blood biomarkers will also be examined, compared between the 2 treatment groups and correlated with the MRI results.

Open or close this module Conditions
Conditions: Rheumatoid Arthritis
Keywords: Magnetic Resonance Imaging
Rituximab
Low Field MRI
Biomarkers
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 60
Open or close this module Arms and Interventions
Intervention Details:
Drug: Rituximab
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24.
Secondary Outcome Measures:
1. Change from Baseline in 1.5 Tesla MRI synovitis score (RAMRIS system) at Week 12.
2. Change from Baseline in 1.5 Tesla MRI bone edema and total score (RAMRIS system) at Week 24.
3. Change from Baseline in 1.5 Tesla MRI bone edema, bone erosion and total score (RAMRIS system) at Week 12 and Week 48.
4. Proportion of patients at Week 48 without new bone erosions on 1.5 Tesla MRI.
5. Change from baseline in total Genant modified Sharp score on conventional radiographs at Week 24 and 48.
6. Change in Disease Activity Score (DAS 28) from Baseline to Week 24 and 48.
7. ACR remission and responder rates (20%, 50%, &)%) at Week 24 and 48.
8. Change from Baseline in functional assessments according to the HAQ scores at 24 and 48 Weeks.
9. Difference between relative results from conventional high-field strength 1.5 Tesla MRI and 0.2 Tesla dedicated extremity MRI in detection and grading of bone erosions, bone edema, and synovitis at Baseline and in Week 12,24, and 48 (C-scan validation).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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 or concurrent treatment with any approved or investigational biologic agent for RA
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Norman B Gaylis, MD
Telephone: 305-652-6676
Email: drnbg@rheum-care.com
Central Contact Backup: Ewa Olech, MD
Telephone: 405-271-7805
Email: ewa-olech@omrf.ouhsc.edu
Study Officials: Norman B Gaylis, MD
Principal Investigator
Arthritis & Rheumatic Disease Specialties
Ewa Olech, M.D.
Principal Investigator
Oklahoma Medical Research Foundation
Locations: United States, Florida
Drs. Charles Kahn and Wayne Riskin
Hollywood, Florida, United States, 33021
Contact:Contact: Joanne Sagliani, BS/CCRC 305-652-6676 drnbg@rheum-care.com
Contact:Sub-Investigator: Charles Kahn, MD
Contact:Sub-Investigator: Wayne Riskin, MD
Arhtritis & Rheumatic Disease Specialties
Miami, Florida, United States, 33180
Contact:Contact: Joanne Sagliani, BS/CCRC 305-652-6676 drnbg@rheum-care.com
Contact:Principal Investigator: Norman B Gaylis, MD
United States, Oklahoma
McBride Clinic Orthopedic Center
Oklahoma City, Oklahoma, United States, 73103
Contact:Contact: Larry Willis, MD 405-232-0341 lwillis@mcbrideclinic.com
Contact:Sub-Investigator: Larry Willis, MD
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Contact:Contact: Angela Genovese, RN 405-271-8001 Ext. 34824 angela-genovese@omrf.ouhsc.edu
Contact:Contact: Fredonna Carthen (405) 271-8001 Ext. 34808 fredonna-carthen@omrf.ouhsc.edu
Contact:Principal Investigator: Ewa Olech, M.D.
Contact:Sub-Investigator: Joan T Merrill, MD
Open or close this module IPDSharing
Plan to Share IPD:
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Links:
Available IPD/Information:

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