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A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00502840
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : September 10, 2014
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: rituximab [MabThera/Rituxan] Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).
Actual Study Start Date : July 23, 2007
Primary Completion Date : September 20, 2011
Study Completion Date : September 20, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in DAS28 Score at Week 24 [ Time Frame: 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.


Secondary Outcome Measures :
  1. DAS28 Score by Treatment Course and Follow-up (FU) Visit [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  2. Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course [ Time Frame: Week 24 ]
    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.

  3. Percentage of Participants Achieving a Response By EULAR Category and Treatment Course [ Time Frame: Week 24 ]
    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.

  4. Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  5. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  6. Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  7. SF-36 MCS by Treatment Course [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  8. SF-36 Domain Scores by Treatment Course - Physical Functioning [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  9. SF-36 Domain Scores by Treatment Course - Bodily Pain [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  10. SF-36 Domain Scores by Treatment Course - Physical Role Functioning [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  11. SF-36 Domain Scores by Treatment Course - Emotional Role Functioning [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  12. SF-36 Domain Scores by Treatment Course - Emotional Well-Being [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  13. SF-36 Domain Scores by Treatment Course - Social Functioning [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  14. SF-36 Domain Scores by Treatment Course - Vitality [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  15. SF-36 Domain Scores by Treatment Course - General Heath Perceptions [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]
    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.

  16. Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course [ Time Frame: 24 weeks after each 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.

  17. Swollen Joint Count [ Time Frame: Screening and Week 24 ]
    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.

  18. Tender Joint Count [ Time Frame: Screening and Week 24 ]
    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.

  19. Physician's Global Assessment of Disease Activity [ Time Frame: Baseline and Week 24 ]
    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).

  20. Patient's Global Assessment of Disease Activity [ Time Frame: Baseline and Week 24 ]
    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).

  21. Patient's Assessment of Pain [ Time Frame: Baseline and Week 24 ]
    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".

  22. C-Reactive Protein [ Time Frame: Baseline and Week 24 ]
    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.

  23. Erythrocyte Sedimentation Rate [ Time Frame: Baseline and Week 24 ]
    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.

  24. Rheumatoid Factor (RF) [ Time Frame: Baseline and Week 24 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
  • eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).

Exclusion Criteria:

  • patients who have withdrawn from treatment in ML19070 pre-week 16;
  • patients with a previous response in DAS28 <0.6 to MabThera after week 16;
  • concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502840


  Hide Study Locations
Locations
Germany
Rheumapraxis - Dres. Edmund Edelmann, Gerhard Straeßner und Hans Bloching
Bad Aibling, Germany, 83043
Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie
Bad Bramstedt, Germany, 24576
Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie
Berlin, Germany, 10117
Praxis Dr. Silke Zinke
Berlin, Germany, 13055
Immanuel-Krankenhaus; Rheumklinik Berlin Buch
Berlin, Germany, 13125
Ev. Waldkrankenhaus Spandau; Klinik für Innere Medizin
Berlin, Germany, 13589
Ambulantes Rheumazentrum Dr.med. Helmut Sörensen
Berlin, Germany, 14163
Universitätsklinikum Bonn Med. Klinik u.Poliklinik III
Bonn, Germany, 53111
HELIOS Seehospital Sahlenburg Abt.Internist.Rheumatologie
Cuxhaven, Germany, 27476
Praxis PD Dr. med. Ekkehard Röther
Donaueschingen, Germany, 78166
Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi
Dresden, Germany, 01109
Med. Versorgungszentrum Kästner + Kästner GbR Ambulantes Rheumazentrum
Erfurt, Germany, 99096
Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie
Erlangen, Germany, 91054
Kliniken Essen; Süd Kath.Krankenhaus St.Josef; Abt. Rheumatologie und Immunologie
Essen, Germany, 45239
Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II; Abt. Rheumatologie
Frankfurt Am Main, Germany, 60590
Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
Freiburg, Germany, 79106
Herz-Jesu-Krankenhaus Abt.Geriatrie u. Rheumatologie
Fulda, Germany, 36039
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik III
Gießen, Germany, 35392
MEDIGREIF Fachkrankenhaus fuer Rheumatologie und Orthopädie; Vogelsang-Gommern
Gommern, Germany, 39245
Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
Hagen, Germany, 58135
Universitätsklinikum Halle Klinik u.Poliklinik f.Innere Medizin I
Halle, Germany, 06120
Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
Hamburg, Germany, 22081
Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
Hannover, Germany, 30625
Rheumapraxis PD Dr.med. Bernhard Heilig
Heidelberg, Germany, 69120
UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
Heidelberg, Germany, 69120
Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
Herne, Germany, 44652
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
Homburg/Saar, Germany, 66421
Universitätsklinikum Jena; Klinik für Innere Medizin III
Jena, Germany, 07747
Praxis Dr.med. Ursula Mauß-Etzler
Karlsruhe, Germany, 76137
Klinik der Uni zu Köln; Klinik für Innere Medizin
Köln, Germany, 50924
Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
Ludwigshafen, Germany, 67063
Praxis Andreas Reck
Mittelherwigsdorf, Germany, 02763
LMU München, Bereich Pettenkoferstr., Medizinische Poliklinik
Muenchen, Germany, 80336
Praxis Prof. Dr.med. Herbert Kellner
München, Germany, 80935
Gemeinschaftspraxis Prof. Dr. med. Klaus Krueger, Guenter Kellerer und Paul Kellerer
München, Germany, 81541
Universitätsklinikum Münster Innere Medizin B
Münster, Germany, 48149
Praxis Dr.med. Sylvia Berger
Naunhof, Germany, 04683
Evang.Krankenhaus Medizinische Klinik
Oldenburg, Germany, 26122
Rheumapraxis an der Hase
Osnabrück, Germany, 49074
Praxis Dr.med. Anett Gräßler
Pirna, Germany, 01796
Evangelisches Fachkrankenhaus; Rheumaklinik
Ratingen, Germany, 40882
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
Regensburg, Germany, 93053
Praxis Dr.med. Matthias Richter
Rostock, Germany, 18059
St.-Josef-Stift Klinik für Rheumatologie
Sendenhorst, Germany, 48324
Rheumatologische Schwerpunktpraxis am Feuersee
Stuttgart, Germany, 70178
Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
Treuenbrietzen, Germany, 14929
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
Tübingen, Germany, 72076
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, Germany, 89081
Praxis Dr.med. Wolf-Dieter Wörth
Wiesbaden, Germany, 65189
Medizinisches Zentrum Betriebsteil Marienhöhe Klinik f.Internistische Rheumatologie
Würselen, Germany, 52146
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, Germany, 97080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502840     History of Changes
Other Study ID Numbers: ML19071
First Posted: July 18, 2007    Key Record Dates
Results First Posted: September 10, 2014
Last Update Posted: August 18, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents