Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis
Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis
1 other identifier
interventional
60
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Feb 2007
Longer than P75 for phase_2 rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2007
CompletedFirst Posted
Study publicly available on registry
January 24, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedAugust 22, 2013
August 1, 2013
4.8 years
January 22, 2007
August 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24.
24 weeks
Secondary Outcomes (9)
Change from Baseline in 1.5 Tesla MRI synovitis score (RAMRIS system) at Week 12.
12 weeks
Change from Baseline in 1.5 Tesla MRI bone edema and total score (RAMRIS system) at Week 24.
24 weeks
Change from Baseline in 1.5 Tesla MRI bone edema, bone erosion and total score (RAMRIS system) at Week 12 and Week 48.
12 and 48 weeks
Proportion of patients at Week 48 without new bone erosions on 1.5 Tesla MRI.
48 weeks
Change from baseline in total Genant modified Sharp score on conventional radiographs at Week 24 and 48.
24 and 48 weeks
- +4 more secondary outcomes
Study Arms (2)
Rituximab/Placebo
NO INTERVENTIONPatients 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.
Open Label
ACTIVE COMPARATORAt 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.
Interventions
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.
Eligibility Criteria
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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gaylis, Norman B., M.D.lead
- Oklahoma Medical Research Foundationcollaborator
- Genentech, Inc.collaborator
Study Sites (6)
Guillermo Valenzuela MD
Fort Lauderdale, Florida, 33324, United States
Drs. Charles Kahn and Wayne Riskin
Hollywood, Florida, 33021, United States
Arhtritis & Rheumatic Disease Specialties
Miami, Florida, 33180, United States
Arthritis and Rheumatology Clinics of Kansas
Wichita, Kansas, 67220, United States
McBride Clinic Orthopedic Center
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Related Publications (1)
Peterfy CG, Olech E, DiCarlo JC, Merrill JT, Countryman PJ, Gaylis NB. Monitoring cartilage loss in the hands and wrists in rheumatoid arthritis with magnetic resonance imaging in a multi-center clinical trial: IMPRESS (NCT00425932). Arthritis Res Ther. 2013 Mar 20;15(2):R44. doi: 10.1186/ar4202.
PMID: 23514433DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman B Gaylis, MD
Arthritis & Rheumatic Disease Specialties
- PRINCIPAL INVESTIGATOR
Ewa Olech, M.D.
Oklahoma Medical Research Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2007
First Posted
January 24, 2007
Study Start
February 1, 2007
Primary Completion
November 1, 2011
Study Completion
November 1, 2012
Last Updated
August 22, 2013
Record last verified: 2013-08