Back to resultsA Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Methotrexate
rituximab [MabThera/Rituxan]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-80 years of age;
- moderate to severe active rheumatoid arthritis;
- inadequate response to previous or current treatment with 1 anti-TNF agent;
- receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.
Exclusion Criteria:
- previous treatment with MabThera;
- use of an anti-TNF alpha agent within 8 weeks of study start;
- concurrent treatment with any DMARD other than methotrexate;
- active infection, or history of serious recurrent or chronic infection.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
AEs, including infusion-related adverse events
Secondary Outcome Measures
Safety of re-treatment (AEs)
Laboratory parameters, vital signs.
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00576433
Brief Title
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Official Title
An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 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 single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
1000mg iv on days 1 and 15
Primary Outcome Measure Information:
Title
AEs, including infusion-related adverse events
Time Frame
For 48 weeks after initial treatment
Secondary Outcome Measure Information:
Title
Safety of re-treatment (AEs)
Time Frame
For 24 weeks after re-treatment.
Title
Laboratory parameters, vital signs.
Time Frame
Throughout study
Title
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.
Time Frame
For 48 weeks after initial treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-80 years of age;
moderate to severe active rheumatoid arthritis;
inadequate response to previous or current treatment with 1 anti-TNF agent;
receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.
Exclusion Criteria:
previous treatment with MabThera;
use of an anti-TNF alpha agent within 8 weeks of study start;
concurrent treatment with any DMARD other than methotrexate;
active infection, or history of serious recurrent or chronic infection.
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
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
City
Irkutsk
ZIP/Postal Code
664047
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
City
Khabarovsk
ZIP/Postal Code
680009
Country
Russian Federation
City
Khanty-Mansiysk
ZIP/Postal Code
628011
Country
Russian Federation
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
Tjumen
ZIP/Postal Code
625023
Country
Russian Federation
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
City
Vladivostok
ZIP/Postal Code
690050
Country
Russian Federation
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
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