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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 1g iv on days 1 and 15 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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 |
|---|---|---|---|---|---|---|
| Budapest | 1023 | Hungary | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab 1000 Milligrams (mg) | Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab 1000 mg | Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | All enrolled participants who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | units on a scale | Day 0 and Week 24 |
|
Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
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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 IV and methylprednisolone 100 mg IV on Days 0 and 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood change | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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 |
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| Methotrexate | Drug | 10-25mg po/week |
|
| Day 0 and Week 24 |
| Anti-cyclic Citrullinated Peptide (Anti-CCP) | Anti-CCP measured as absorbance units per milliliter (AU/mL). | Day 0 and Week 24 |
| Vascular Endothelial Growth Factor (VEGF) | VEGF was measured as picograms per milliliter (pg/mL). | Day 0 and Week 24 |
| Erythrocyte Sedimentation Rate (ESR) | ESR was measured in mm/hr. | Day 0 and Week 24 |
| C-Reactive Protein (CRP) | CRP was measured in milligrams per liter (mg/L). | Day 0 and Week 24 |
| Budapest |
| 1027 |
| Hungary |
| Debrecen | 4032 | Hungary |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | 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). | All enrolled participants. n (number) = number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Day 0 and Week 24 |
|
|
|
|
| Secondary | Anti-cyclic Citrullinated Peptide (Anti-CCP) | Anti-CCP measured as absorbance units per milliliter (AU/mL). | All participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | AU/mL | Day 0 and Week 24 |
|
|
|
| Secondary | Vascular Endothelial Growth Factor (VEGF) | VEGF was measured as picograms per milliliter (pg/mL). | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | pg/mL | Day 0 and Week 24 |
|
|
|
| Secondary | Erythrocyte Sedimentation Rate (ESR) | ESR was measured in mm/hr. | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mm/hr | Day 0 and Week 24 |
|
|
|
|
| Secondary | C-Reactive Protein (CRP) | CRP was measured in milligrams per liter (mg/L). | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mg/L | Day 0 and Week 24 |
|
|
|
|
| 0 |
| 20 |
| 9 |
| 20 |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Blood in stool | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Throat pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA | Non-systematic Assessment |
|
| Dry eye sensation | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Feeling of weakness | General disorders | MedDRA | Non-systematic Assessment |
|
| Sleep disturbance | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Leucopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Progression of rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Haemorrhagic suffusion | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Acute conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Infusion site pruritus | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Infusion site swelling | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 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 |