Back to resultsA Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
rituximab [MabThera/Rituxan]
placebo
methotrexate
rituximab [Mabthera/Rituxan]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-75 years of age
- active rheumatoid arthritis (DAS28-CRP>3.2)
- refractory to one or more anti-TNF
- on stable treatment for RA for >/=4 weeks
- evidence of erosive disease and/or synovitis in wrist and/or knuckles
Exclusion Criteria:
- active systemic or local infection
- previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
- signs of immunodeficiency, HIV infection or tuberculosis
- contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
Secondary Outcome Measures
Synovitis score on MRI using RAMRIS
Bone edema score on MRI using RAMRIS
Bone erosion score on MRI using RAMRIS
Disease activity according to DAS28-CRP
Tender or swollen joint count (ACR criteria)
Health assessment questionnaire (HAQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01117129
Brief Title
A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)
Official Title
Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
This study was prematurely terminated as 2 patients were recruited and both of them withdrawn from the study before reaching the primary end point.
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is <50 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
1000 mg by i.v. infusion on day 1 and 15
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
i.v. infusion on day 1 and 15
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
10-25 mg weekly
Intervention Type
Drug
Intervention Name(s)
rituximab [Mabthera/Rituxan]
Intervention Description
1000 mg by i.v. infusion on day 1 and 15, 2nd and further cycles in patients with (group A) or without (group B) clinical response in cycle 1
Primary Outcome Measure Information:
Title
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Synovitis score on MRI using RAMRIS
Time Frame
months 6, 12 and 24
Title
Bone edema score on MRI using RAMRIS
Time Frame
months 6, 12 and 24
Title
Bone erosion score on MRI using RAMRIS
Time Frame
months 12 and 24
Title
Disease activity according to DAS28-CRP
Time Frame
months 12 and 24
Title
Tender or swollen joint count (ACR criteria)
Time Frame
months 12 and 24
Title
Health assessment questionnaire (HAQ)
Time Frame
months 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-75 years of age
active rheumatoid arthritis (DAS28-CRP>3.2)
refractory to one or more anti-TNF
on stable treatment for RA for >/=4 weeks
evidence of erosive disease and/or synovitis in wrist and/or knuckles
Exclusion Criteria:
active systemic or local infection
previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
signs of immunodeficiency, HIV infection or tuberculosis
contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)
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