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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ritxumab | Experimental | all patients get treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | treatment with rituximab |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology (ACR) 20 at Week 12 | ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP). | 0 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Kavanaugh, MD | UCSD CIT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD CIT | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17644541 | Background | Kavanaugh A, Rosengren S, Lee SJ, Hammaker D, Firestein GS, Kalunian K, Wei N, Boyle DL. Assessment of rituximab's immunomodulatory synovial effects (ARISE trial). 1: clinical and synovial biomarker results. Ann Rheum Dis. 2008 Mar;67(3):402-8. doi: 10.1136/ard.2007.074229. Epub 2007 Jul 20. | |
| 18761748 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ritxumab | Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ritxumab | Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | American College of Rheumatology (ACR) 20 at Week 12 | ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP). | Posted | Number | participants | 0 and 12 weeks |
|
|
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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 | Ritxumab | Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | considered not related to study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction to detergent on hand and arm | Immune system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Kavanaugh | UCSD | 858-657-7040 | akavanaugh@ucsd.edu |
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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 |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rosengren S, Wei N, Kalunian KC, Zvaifler NJ, Kavanaugh A, Boyle DL. Elevated autoantibody content in rheumatoid arthritis synovia with lymphoid aggregates and the effect of rituximab. Arthritis Res Ther. 2008;10(5):R105. doi: 10.1186/ar2497. Epub 2008 Sep 1. |
| 21098574 | Derived | Rosengren S, Wei N, Kalunian KC, Kavanaugh A, Boyle DL. CXCL13: a novel biomarker of B-cell return following rituximab treatment and synovitis in patients with rheumatoid arthritis. Rheumatology (Oxford). 2011 Mar;50(3):603-10. doi: 10.1093/rheumatology/keq337. Epub 2010 Nov 23. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 2 |
| 24 |
| 21 |
| 24 |
|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment | considered not related to study drug |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | considered not related to treatment with study drug |
|
| Hot/cold flashes | General disorders |
|
| Contact dimities | Skin and subcutaneous tissue disorders |
|
| Edema | Vascular disorders |
|
| Excessive vaginal bleeding | Reproductive system and breast disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Deep venous thrombosis | Vascular disorders |
|
| Leg small vessel bursting | Vascular disorders |
|
| Spider veins | Vascular disorders |
|
| Headache | Nervous system disorders |
|
| Sinus headache | Immune system disorders |
|
| Dizziness | Nervous system disorders |
|
| Fatigue | General disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Endometriosis | Reproductive system and breast disorders |
|
| Insomnia | Nervous system disorders |
|
| Hair loss | Skin and subcutaneous tissue disorders |
|
| Fall | General disorders |
|
| Lacerated forehead | Injury, poisoning and procedural complications |
|
| Hiatal hernia | Gastrointestinal disorders |
|
| Corrective surgery, hammer toes | Surgical and medical procedures |
|
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| 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 |