Back to resultsA Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
rituximab [MabThera/Rituxan]
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- diagnosed RA for >=3 months prior to first administration of study medication;
- inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
- if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.
Exclusion Criteria:
- other chronic inflammatory diseases;
- use of parental corticosteroids within 4 weeks prior to screening;
- severe heart failure, or severe, uncontrolled cardiac disease.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Disease Activity Score Based on 28-Joint Count (DAS28)
DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.
Secondary Outcome Measures
Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores
The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).
Anti-cyclic Citrullinated Peptide (Anti-CCP)
Anti-CCP measured as absorbance units per milliliter (AU/mL).
Vascular Endothelial Growth Factor (VEGF)
VEGF was measured as picograms per milliliter (pg/mL).
Erythrocyte Sedimentation Rate (ESR)
ESR was measured in mm/hr.
C-Reactive Protein (CRP)
CRP was measured in milligrams per liter (mg/L).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00424502
Brief Title
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Official Title
An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (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 efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). 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
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Other Intervention Name(s)
MabThera/Rituxan
Intervention Description
1g iv on days 1 and 15
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
10-25mg po/week
Primary Outcome Measure Information:
Title
Disease Activity Score Based on 28-Joint Count (DAS28)
Description
DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.
Time Frame
Day 0 and Week 24
Secondary Outcome Measure Information:
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores
Description
The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).
Time Frame
Day 0 and Week 24
Title
Anti-cyclic Citrullinated Peptide (Anti-CCP)
Description
Anti-CCP measured as absorbance units per milliliter (AU/mL).
Time Frame
Day 0 and Week 24
Title
Vascular Endothelial Growth Factor (VEGF)
Description
VEGF was measured as picograms per milliliter (pg/mL).
Time Frame
Day 0 and Week 24
Title
Erythrocyte Sedimentation Rate (ESR)
Description
ESR was measured in mm/hr.
Time Frame
Day 0 and Week 24
Title
C-Reactive Protein (CRP)
Description
CRP was measured in milligrams per liter (mg/L).
Time Frame
Day 0 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
diagnosed RA for >=3 months prior to first administration of study medication;
inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.
Exclusion Criteria:
other chronic inflammatory diseases;
use of parental corticosteroids within 4 weeks prior to screening;
severe heart failure, or severe, uncontrolled cardiac disease.
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
Budapest
ZIP/Postal Code
1023
Country
Hungary
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
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 TNF-Blocker.
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