Clinical trial NCT00502840: 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.
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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* patients who have withdrawn from treatment in ML19070 pre-week 16;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

Primary outcomes:
measure: Change From Baseline in DAS28 Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: DAS28 Score by Treatment Course and Follow-up (FU) Visit
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course
timeFrame: Week 24
measure: Percentage of Participants Achieving a Response By EULAR Category and Treatment Course
timeFrame: Week 24
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 MCS by Treatment Course
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Physical Functioning
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Bodily Pain
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Physical Role Functioning
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Emotional Role Functioning
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Emotional Well-Being
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Social Functioning
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - Vitality
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: SF-36 Domain Scores by Treatment Course - General Heath Perceptions
timeFrame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course
timeFrame: 24 weeks after each course
measure: Swollen Joint Count
timeFrame: Screening and Week 24
measure: Tender Joint Count
timeFrame: Screening and Week 24
measure: Physician's Global Assessment of Disease Activity
timeFrame: Baseline and Week 24
measure: Patient's Global Assessment of Disease Activity
timeFrame: Baseline and Week 24
measure: Patient's Assessment of Pain
timeFrame: Baseline and Week 24
measure: C-Reactive Protein
timeFrame: Baseline and Week 24
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline and Week 24
measure: Rheumatoid Factor (RF)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Bad Aibling
country: Germany
facility: Rheumapraxis - Dres. Edmund Edelmann, Gerhard Straeßner und Hans Bloching
city: Bad Bramstedt
country: Germany
facility: Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie
city: Berlin
country: Germany
facility: Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie
city: Berlin
country: Germany
facility: Praxis Dr. Silke Zinke
city: Berlin
country: Germany
facility: Immanuel-Krankenhaus; Rheumklinik Berlin Buch
city: Berlin
country: Germany
facility: Ev. Waldkrankenhaus Spandau; Klinik für Innere Medizin
city: Berlin
country: Germany
facility: Ambulantes Rheumazentrum Dr.med. Helmut Sörensen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn Med. Klinik u.Poliklinik III
city: Cuxhaven
country: Germany
facility: HELIOS Seehospital Sahlenburg Abt.Internist.Rheumatologie
city: Donaueschingen
country: Germany
facility: Praxis PD Dr. med. Ekkehard Röther
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi
city: Erfurt
country: Germany
facility: Med. Versorgungszentrum Kästner + Kästner GbR Ambulantes Rheumazentrum
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie
city: Essen
country: Germany
facility: Kliniken Essen; Süd Kath.Krankenhaus St.Josef; Abt. Rheumatologie und Immunologie
city: Frankfurt Am Main
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II; Abt. Rheumatologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
city: Fulda
country: Germany
facility: Herz-Jesu-Krankenhaus Abt.Geriatrie u. Rheumatologie
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik III
city: Gommern
country: Germany
facility: MEDIGREIF Fachkrankenhaus fuer Rheumatologie und Orthopädie; Vogelsang-Gommern
city: Hagen
country: Germany
facility: Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
city: Halle
country: Germany
facility: Universitätsklinikum Halle Klinik u.Poliklinik f.Innere Medizin I
city: Hamburg
country: Germany
facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
city: Heidelberg
country: Germany
facility: Rheumapraxis PD Dr.med. Bernhard Heilig
city: Heidelberg
country: Germany
facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
city: Herne
country: Germany
facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
city: Jena
country: Germany
facility: Universitätsklinikum Jena; Klinik für Innere Medizin III
city: Karlsruhe
country: Germany
facility: Praxis Dr.med. Ursula Mauß-Etzler
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Klinik für Innere Medizin
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
city: Mittelherwigsdorf
country: Germany
facility: Praxis Andreas Reck
city: Muenchen
country: Germany
facility: LMU München, Bereich Pettenkoferstr., Medizinische Poliklinik
city: München
country: Germany
facility: Praxis Prof. Dr.med. Herbert Kellner
city: München
country: Germany
facility: Gemeinschaftspraxis Prof. Dr. med. Klaus Krueger, Guenter Kellerer und Paul Kellerer
city: Münster
country: Germany
facility: Universitätsklinikum Münster Innere Medizin B
city: Naunhof
country: Germany
facility: Praxis Dr.med. Sylvia Berger
city: Oldenburg
country: Germany
facility: Evang.Krankenhaus Medizinische Klinik
city: Osnabrück
country: Germany
facility: Rheumapraxis an der Hase
city: Pirna
country: Germany
facility: Praxis Dr.med. Anett Gräßler
city: Ratingen
country: Germany
facility: Evangelisches Fachkrankenhaus; Rheumaklinik
city: Regensburg
country: Germany
facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
city: Rostock
country: Germany
facility: Praxis Dr.med. Matthias Richter
city: Sendenhorst
country: Germany
facility: St.-Josef-Stift Klinik für Rheumatologie
city: Stuttgart
country: Germany
facility: Rheumatologische Schwerpunktpraxis am Feuersee
city: Treuenbrietzen
country: Germany
facility: Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
city: Wiesbaden
country: Germany
facility: Praxis Dr.med. Wolf-Dieter Wörth
city: Würselen
country: Germany
facility: Medizinisches Zentrum Betriebsteil Marienhöhe Klinik f.Internistische Rheumatologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: