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This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg 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 the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 1000mg iv on days 1 and 15 |
| |
| methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE) | Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score Based on 28-Joint Count (DAS28) | DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casablanca | 20000 | Morocco | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab 1000 Milligrams (mg) | Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
10-25mg weekly |
|
| Day 1 and Week 24 |
| Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category | DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | Screening, Day 1, and Weeks 24 and 104 |
| Percentage of Participants With Changes in Bone Density | Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available. | Screening, Weeks 48 and 104 |
| Casablanca |
| 20100 |
| Morocco |
| Marrakesh | 40000 | Morocco |
| Rabat | 10150 | Morocco |
| Salé | 15045 | Morocco |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population: all participants who received any part of an infusion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab 1000 mg | Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Adverse Event (AE) | Safety population: included all participants who have received any part of an infusion of the study medication. | Posted | Number | percentage of participants | Week 104 |
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| |||||||||||||||||||||||||||
| Secondary | Disease Activity Score Based on 28-Joint Count (DAS28) | DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity. | ITT population | Posted | Mean | Standard Deviation | scores on a scale | Day 1 and Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category | DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | ITT population | Posted | Number | percentage of participants | Screening, Day 1, and Weeks 24 and 104 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Changes in Bone Density | Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available. | ITT population | Posted | Number | percentage of participants | Screening, Weeks 48 and 104 |
|
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Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab 1000 mg | Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines. | 0 | 15 | 4 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | MedDRA | Non-systematic Assessment |
| |
| Scalp infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash of face | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Diffuse skin rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tightening of throat and tongue | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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