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.

Last updated: July 11, 2017
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00502840
ML19071
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients with rheumatoid arthritis who participated in ML19070, and havecompleted the week 24 visit;

  • eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tenderjoint count >=4).

Exclusion

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  • patients who have withdrawn from treatment in ML19070 pre-week 16;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.

Study Design

Total Participants: 193
Study Start date:
July 23, 2007
Estimated Completion Date:
September 20, 2011

Connect with a study center

  • Rheumapraxis - Dres. Edmund Edelmann, Gerhard Straeßner und Hans Bloching

    Bad Aibling, 83043
    Germany

    Site Not Available

  • Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie

    Bad Bramstedt, 24576
    Germany

    Site Not Available

  • Ambulantes Rheumazentrum Dr.med. Helmut Sörensen

    Berlin, 14163
    Germany

    Site Not Available

  • Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie

    Berlin, 10117
    Germany

    Site Not Available

  • Ev. Waldkrankenhaus Spandau; Klinik für Innere Medizin

    Berlin, 13589
    Germany

    Site Not Available

  • Immanuel-Krankenhaus; Rheumklinik Berlin Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Praxis Dr. Silke Zinke

    Berlin, 13055
    Germany

    Site Not Available

  • Universitätsklinikum Bonn Med. Klinik u.Poliklinik III

    Bonn, 53111
    Germany

    Site Not Available

  • HELIOS Seehospital Sahlenburg Abt.Internist.Rheumatologie

    Cuxhaven, 27476
    Germany

    Site Not Available

  • Praxis PD Dr. med. Ekkehard Röther

    Donaueschingen, 78166
    Germany

    Site Not Available

  • Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi

    Dresden, 01109
    Germany

    Site Not Available

  • Med. Versorgungszentrum Kästner + Kästner GbR Ambulantes Rheumazentrum

    Erfurt, 99096
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie

    Erlangen, 91054
    Germany

    Site Not Available

  • Kliniken Essen; Süd Kath.Krankenhaus St.Josef; Abt. Rheumatologie und Immunologie

    Essen, 45239
    Germany

    Site Not Available

  • Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II; Abt. Rheumatologie

    Frankfurt Am Main, 60590
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie

    Freiburg, 79106
    Germany

    Site Not Available

  • Herz-Jesu-Krankenhaus Abt.Geriatrie u. Rheumatologie

    Fulda, 36039
    Germany

    Site Not Available

  • empty

    GIEßEN, 35392
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik III

    Gießen, 35392
    Germany

    Site Not Available

  • MEDIGREIF Fachkrankenhaus fuer Rheumatologie und Orthopädie; Vogelsang-Gommern

    Gommern, 39245
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik

    Hagen, 58135
    Germany

    Site Not Available

  • Universitätsklinikum Halle Klinik u.Poliklinik f.Innere Medizin I

    Halle, 06120
    Germany

    Site Not Available

  • Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

    Hamburg, 22081
    Germany

    Site Not Available

  • Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

    Hannover, 30625
    Germany

    Site Not Available

  • Rheumapraxis PD Dr.med. Bernhard Heilig

    Heidelberg, 69120
    Germany

    Site Not Available

  • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

    Heidelberg, 69120
    Germany

    Site Not Available

  • Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

    Herne, 44652
    Germany

    Site Not Available

  • empty

    Homburg, 66424
    Germany

    Site Not Available

  • Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

    Homburg/Saar, 66421
    Germany

    Site Not Available

  • Universitätsklinikum Jena; Klinik für Innere Medizin III

    Jena, 07747
    Germany

    Site Not Available

  • Praxis Dr.med. Ursula Mauß-Etzler

    Karlsruhe, 76137
    Germany

    Site Not Available

  • empty

    Koeln, 50924
    Germany

    Site Not Available

  • empty

    Köln, 50924
    Germany

    Site Not Available

  • Klinik der Uni zu Köln; Klinik für Innere Medizin

    Köln, 50924
    Germany

    Site Not Available

  • Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

    Ludwigshafen, 67063
    Germany

    Site Not Available

  • Praxis Andreas Reck

    Mittelherwigsdorf, 02763
    Germany

    Site Not Available

  • LMU München, Bereich Pettenkoferstr., Medizinische Poliklinik

    Muenchen, 80336
    Germany

    Site Not Available

  • empty

    München, 81541
    Germany

    Site Not Available

  • empty

    Münster, 48149
    Germany

    Site Not Available

  • Gemeinschaftspraxis Prof. Dr. med. Klaus Krueger, Guenter Kellerer und Paul Kellerer

    München, 81541
    Germany

    Site Not Available

  • Praxis Prof. Dr.med. Herbert Kellner

    München, 80935
    Germany

    Site Not Available

  • Universitätsklinikum Münster Innere Medizin B

    Münster, 48149
    Germany

    Site Not Available

  • Praxis Dr.med. Sylvia Berger

    Naunhof, 04683
    Germany

    Site Not Available

  • Evang.Krankenhaus Medizinische Klinik

    Oldenburg, 26122
    Germany

    Site Not Available

  • empty

    Osnabrück, 49074
    Germany

    Site Not Available

  • Rheumapraxis an der Hase

    Osnabrück, 49074
    Germany

    Site Not Available

  • Praxis Dr.med. Anett Gräßler

    Pirna, 01796
    Germany

    Site Not Available

  • Evangelisches Fachkrankenhaus; Rheumaklinik

    Ratingen, 40882
    Germany

    Site Not Available

  • Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

    Regensburg, 93053
    Germany

    Site Not Available

  • Praxis Dr.med. Matthias Richter

    Rostock, 18059
    Germany

    Site Not Available

  • St.-Josef-Stift Klinik für Rheumatologie

    Sendenhorst, 48324
    Germany

    Site Not Available

  • Rheumatologische Schwerpunktpraxis am Feuersee

    Stuttgart, 70178
    Germany

    Site Not Available

  • Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie

    Treuenbrietzen, 14929
    Germany

    Site Not Available

  • empty

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

    Ulm, 89081
    Germany

    Site Not Available

  • empty

    Villingen-schwenningen, 78054
    Germany

    Site Not Available

  • Praxis Dr.med. Wolf-Dieter Wörth

    Wiesbaden, 65189
    Germany

    Site Not Available

  • empty

    Wuerzburg, 97080
    Germany

    Site Not Available

  • empty

    Würselen, 52146
    Germany

    Site Not Available

  • empty

    Würzburg, 97080
    Germany

    Site Not Available

  • Medizinisches Zentrum Betriebsteil Marienhöhe Klinik f.Internistische Rheumatologie

    Würselen, 52146
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

    Würzburg, 97080
    Germany

    Site Not Available

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