Back to resultsA Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Tunisia
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 years of age
- rheumatoid arthritis DAS28 >/= 3.2
- receiving treatment on an outpatient basis
- experienced an inadequate response to previous or current treatment with methotrexate
Exclusion Criteria:
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any cell-depleting therapies
Sites / Locations
- Hopital Farhat Hached; Service Rhumatologie
- Hopital Charles Nicole; Service Rhumatologie
- Hopital La Rabta; Service Rhumatologie
- Hopital Mongi Slim; Service Rhumatologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Reporting Adverse Events (AEs)
Secondary Outcome Measures
Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.
Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.
Change in Bone Density (in Participants Untreated With Bisphosphonates)
Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01000610
Brief Title
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Official Title
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 17, 2008 (Actual)
Primary Completion Date
May 16, 2012 (Actual)
Study Completion Date
May 16, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is <50
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
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
1000 mg iv infusion on days 1 and 15
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
10-25 mg weekly (oral or parenteral)
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
100 mg iv prior to each rituximab infusion
Primary Outcome Measure Information:
Title
Number of Participants Reporting Adverse Events (AEs)
Time Frame
Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks
Secondary Outcome Measure Information:
Title
Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
Description
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.
Time Frame
Baseline and Week 24
Title
Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
Description
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.
Time Frame
Baseline and Week 24
Title
Change in Bone Density (in Participants Untreated With Bisphosphonates)
Description
Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.
Time Frame
Screening and Week 84
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
rheumatoid arthritis DAS28 >/= 3.2
receiving treatment on an outpatient basis
experienced an inadequate response to previous or current treatment with methotrexate
Exclusion Criteria:
rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
history of or current inflammatory joint disease other than RA
previous treatment with any cell-depleting therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Farhat Hached; Service Rhumatologie
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Hopital Charles Nicole; Service Rhumatologie
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
Facility Name
Hopital La Rabta; Service Rhumatologie
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Hopital Mongi Slim; Service Rhumatologie
City
Tunis
ZIP/Postal Code
2046
Country
Tunisia
12. IPD Sharing Statement
Learn more about this trial
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
We'll reach out to this number within 24 hrs