Back to resultsA Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Serbia
Study Type
Interventional
Intervention
rituximab [MabThera/Rituxan]
methotrexate
methylprednisolone
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;
- rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
- active disease;
- DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.
Exclusion Criteria:
- autoimmune disease other than rheumatoid arthritis;
- bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
- concurrent treatment with any DMARD or antiTNF-alfa;
- intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MabThera/Rituxan
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Secondary Outcome Measures
Health Assessment Questionnaire-Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02006706
Brief Title
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Official Title
An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 10, 2006 (Actual)
Primary Completion Date
November 23, 2007 (Actual)
Study Completion Date
November 23, 2007 (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 study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MabThera/Rituxan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
1000 mg iv Days 1 and 15
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
10 - 25 mg/week
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion
Primary Outcome Measure Information:
Title
Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
Description
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame
Baseline, Week 24
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;
rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
active disease;
DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.
Exclusion Criteria:
autoimmune disease other than rheumatoid arthritis;
bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
concurrent treatment with any DMARD or antiTNF-alfa;
intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
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
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Niska Banja
ZIP/Postal Code
18250
Country
Serbia
City
Nova Sad
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
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