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This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 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 |
|---|---|---|
| Change From Baseline in DAS28 Score at Week 24 | DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| DAS28 Score by Treatment Course and Follow-up (FU) Visit | DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) 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 >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 |
|---|---|---|---|---|---|---|
| Rheumapraxis - Dres. Edmund Edelmann, Gerhard Straeßner und Hans Bloching | Bad Aibling | 83043 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38261093 | Derived | Dimanche A, Bervini D, Miller DR, Schar A, Goldberg J, Raabe A, Dunn AK. Cortical perfusion measurements with laser speckle contrast imaging during adenosine induced cardiac arrest for aneurysm clipping: a case report. Acta Neurochir (Wien). 2024 Jan 23;166(1):27. doi: 10.1007/s00701-024-05925-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab Plus Methotrexate (MTX) | Participants received rituximab 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course | DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. | Week 24 |
| Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1. | Week 24 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). 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 sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 MCS by Treatment Course | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Physical Functioning | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Bodily Pain | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Physical Role Functioning | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Emotional Well-Being | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Social Functioning | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - Vitality | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| SF-36 Domain Scores by Treatment Course - General Heath Perceptions | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit. | 24 weeks after each course |
| Swollen Joint Count | Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. | Screening and Week 24 |
| Tender Joint Count | Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. | Screening and Week 24 |
| Physician's Global Assessment of Disease Activity | Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). | Baseline and Week 24 |
| Patient's Global Assessment of Disease Activity | Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). | Baseline and Week 24 |
| Patient's Assessment of Pain | Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain". | Baseline and Week 24 |
| C-Reactive Protein | CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. | Baseline and Week 24 |
| Erythrocyte Sedimentation Rate | ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. | Baseline and Week 24 |
| Rheumatoid Factor (RF) | RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. | Baseline and Week 24 |
| Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie |
| Bad Bramstedt |
| 24576 |
| Germany |
| Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie | Berlin | 10117 | Germany |
| Praxis Dr. Silke Zinke | Berlin | 13055 | Germany |
| Immanuel-Krankenhaus; Rheumklinik Berlin Buch | Berlin | 13125 | Germany |
| Ev. Waldkrankenhaus Spandau; Klinik für Innere Medizin | Berlin | 13589 | Germany |
| Ambulantes Rheumazentrum Dr.med. Helmut Sörensen | Berlin | 14163 | Germany |
| Universitätsklinikum Bonn Med. Klinik u.Poliklinik III | Bonn | 53111 | Germany |
| Klinik der Uni zu Köln; Klinik für Innere Medizin | Cologne | 50924 | Germany |
| HELIOS Seehospital Sahlenburg Abt.Internist.Rheumatologie | Cuxhaven | 27476 | Germany |
| Praxis PD Dr. med. Ekkehard Röther | Donaueschingen | 78166 | Germany |
| Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi | Dresden | 01109 | Germany |
| Med. Versorgungszentrum Kästner + Kästner GbR Ambulantes Rheumazentrum | Erfurt | 99096 | Germany |
| Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie | Erlangen | 91054 | Germany |
| Kliniken Essen; Süd Kath.Krankenhaus St.Josef; Abt. Rheumatologie und Immunologie | Essen | 45239 | Germany |
| Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II; Abt. Rheumatologie | Frankfurt am Main | 60590 | Germany |
| Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie | Freiburg im Breisgau | 79106 | Germany |
| Herz-Jesu-Krankenhaus Abt.Geriatrie u. Rheumatologie | Fulda | 36039 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik III | Giessen | 35392 | Germany |
| MEDIGREIF Fachkrankenhaus fuer Rheumatologie und Orthopädie; Vogelsang-Gommern | Gommern | 39245 | Germany |
| Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik | Hagen | 58135 | Germany |
| Universitätsklinikum Halle Klinik u.Poliklinik f.Innere Medizin I | Halle | 06120 | Germany |
| Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie | Hamburg | 22081 | Germany |
| Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie | Hanover | 30625 | Germany |
| Rheumapraxis PD Dr.med. Bernhard Heilig | Heidelberg | 69120 | Germany |
| UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V | Heidelberg | 69120 | Germany |
| Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie | Herne | 44652 | Germany |
| Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I | Homburg/Saar | 66421 | Germany |
| Universitätsklinikum Jena; Klinik für Innere Medizin III | Jena | 07747 | Germany |
| Praxis Dr.med. Ursula Mauß-Etzler | Karlsruhe | 76137 | Germany |
| Klinikum der Stadt Ludwigshafen; Medizinische Klinik A | Ludwigshafen | 67063 | Germany |
| Praxis Andreas Reck | Mittelherwigsdorf | 02763 | Germany |
| LMU München, Bereich Pettenkoferstr., Medizinische Poliklinik | München | 80336 | Germany |
| Praxis Prof. Dr.med. Herbert Kellner | München | 80935 | Germany |
| Gemeinschaftspraxis Prof. Dr. med. Klaus Krueger, Guenter Kellerer und Paul Kellerer | München | 81541 | Germany |
| Universitätsklinikum Münster Innere Medizin B | Münster | 48149 | Germany |
| Praxis Dr.med. Sylvia Berger | Naunhof | 04683 | Germany |
| Evang.Krankenhaus Medizinische Klinik | Oldenburg | 26122 | Germany |
| Rheumapraxis an der Hase | Osnabrück | 49074 | Germany |
| Praxis Dr.med. Anett Gräßler | Pirna | 01796 | Germany |
| Evangelisches Fachkrankenhaus; Rheumaklinik | Ratingen | 40882 | Germany |
| Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie | Regensburg | 93053 | Germany |
| Praxis Dr.med. Matthias Richter | Rostock | 18059 | Germany |
| St.-Josef-Stift Klinik für Rheumatologie | Sendenhorst | 48324 | Germany |
| Rheumatologische Schwerpunktpraxis am Feuersee | Stuttgart | 70178 | Germany |
| Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie | Treuenbrietzen | 14929 | Germany |
| Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo. | Ulm | 89081 | Germany |
| Praxis Dr.med. Wolf-Dieter Wörth | Wiesbaden | 65189 | Germany |
| Medizinisches Zentrum Betriebsteil Marienhöhe Klinik f.Internistische Rheumatologie | Würselen | 52146 | Germany |
| Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie | Würzburg | 97080 | Germany |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety Population: all participants who received at least 1 dose of the trial medication and had at least 1 safety follow-up, whether withdrawn prematurely or not. A safety follow-up was assumed if the participant had at least 1 documented study visit after baseline or if at least 1 adverse event had been documented with start date after baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab Plus MTX | Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change From Baseline in DAS28 Score at Week 24 | DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units. | Intent-to-Treat (ITT) Population: all participants who signed the informed consent form, received at least 1 dose of study medication, and where the DAS28 was measured at least once under study medication. | Posted | Mean | Standard Deviation | scores on a scale | Week 24 |
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| Secondary | DAS28 Score by Treatment Course and Follow-up (FU) Visit | DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) 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 >3.2 to 5.1 = moderate to high disease activity. | ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course | DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). 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 sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 MCS by Treatment Course | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Physical Functioning | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Bodily Pain | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Social Functioning | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - Vitality | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | scores on a scale | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Number | percentage of participants | 24 weeks after each course |
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| Secondary | Swollen Joint Count | Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | swollen joints | Screening and Week 24 |
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| Secondary | Tender Joint Count | Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | tender joints | Screening and Week 24 |
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| Secondary | Physician's Global Assessment of Disease Activity | Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
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| Secondary | Patient's Global Assessment of Disease Activity | Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
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| Secondary | Patient's Assessment of Pain | Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain". | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
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| Secondary | C-Reactive Protein | CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
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| Secondary | Erythrocyte Sedimentation Rate | ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mm/hr | Baseline and Week 24 |
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| Secondary | Rheumatoid Factor (RF) | RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | IU/mL | Baseline and Week 24 |
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|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab Plus MTX | Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment. | 47 | 193 | 105 | 193 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gangrene | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Toxic nodular goitre | Endocrine disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dilatation ventricular | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Heart valve insufficiency | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Eye infection bacterial | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Infected epidermal cyst | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Transient psychosis | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acrodermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nail bed inflammation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urticaria localised | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 10.0 | 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.
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| 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 |
Not provided
Not provided
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